| Placebo b.i.d. (n = 3) | Placebo t.i.d. (n = 15) | Placebo total (n = 18) | GSK2982772 60 mg b.i.d. (n = 5) | GSK2982772 60 mg t.i.d. (n = 28) | GSK2982772 60 mg total (n = 33) |
---|---|---|---|---|---|---|
Any AE, n (%) | 3 (100) | 10 (67) | 13 (72) | 3 (60) | 17 (61) | 20 (61) |
Any SAE, n (%) | 0 | 0 | 0 | 0 | 2 (7) | 2 (6) |
 Eye disorder | ||||||
  Retinal vein thrombosis | 0 | 0 | 0 | 0 | 1 (4) | 1 (3) |
 Injury, poisoning and procedural complications | ||||||
  Multiple fractures | 0 | 0 | 0 | 0 | 1 (4) | 1 (3) |
Any AE leading to withdrawal, n (%) | 0 | 0 | 0 | 0 | 3 (11) | 3 (9) |
 Infections and infestations | ||||||
  Bronchitis | 0 | 0 | 0 | 0 | 1 (4) | 1 (3) |
 Eye disorder | ||||||
  Retinal vein thrombosis (SAE) | 0 | 0 | 0 | 0 | 1 (4) | 1 (3) |
 Injury, poisoning, and procedural complications | ||||||
  Multiple fractures (SAE) | 0 | 0 | 0 | 0 | 1 (4) | 1 (3) |
Any treatment-related AEs, n (%) | 3 (100) | 2 (13) | 5 (28) | 1 (20) | 6 (21) | 7 (21) |
 Severe | 0 | 0 | 0 | 0 | 1 (4) | 1 (3) |
 Moderate | 1 (33) | 1 (7) | 2 (11) | 1 (20) | 4 (14) | 5 (15) |
 Mild | 2 (67) | 1 (7) | 3 (17) | 0 | 1 (4) | 1 (3) |
AEs occurring in > 10% of combined groups, n (%) | ||||||
 Musculoskeletal and connective tissue disorders | ||||||
  Arthralgia |  | 2 (11) |  | 2 (6) | ||
 Nervous system disorders | ||||||
  Headache |  | 2 (11) |  | 1 (3) | ||
 General disorders and administration site conditions |  | |||||
  Peripheral swellinga |  | 2 (11) |  | 0 |