Table 2.
Adverse events
| n (%) | Placebo (N = 18) | 60 mg b.i.d. (N = 23) | 60 mg t.i.d. (N = 24) | Total (N = 65 a ) |
|---|---|---|---|---|
| Any event | 8 (44) | 21 (91) | 16 (67) | 45 (69) |
| AE by severity | ||||
| Serious AE | 0 | 2 (9) | 0 | 2 (3) |
| Moderate AE | 3 (17) | 10 (43) | 3 (13) | 16 (25) |
| Mild AE | 5 (28) | 9 (39) | 13 (54) | 27 (42) |
| Most frequent AE | ||||
| Nasopharyngitis | 4 (22) | 7 (30) | 7 (29) | 18 (28) |
| Headache | 4 (22) | 10 (43) | 3 (13) | 17 (26) |
| Arthralgia | 0 | 1 (4) | 2 (8) | 3 (5) |
| Back pain | 2 (11) | 0 | 1 (4) | 3 (5) |
| Cough | 0 | 2 (9) | 1 (4) | 3 (5) |
| Diarrhea | 2 (11) | 1 (4) | 0 | 3 (5) |
| Fatigue | 0 | 3 (13) | 0 | 3 (5) |
| Nausea | 1 (6) | 1 (4) | 1 (4) | 3 (5) |
| Upper respiratory tract infection | 0 | 2 (9) | 1 (4) | 3 (5) |
| Decreased appetite | 0 | 1 (4) | 1 (4) | 2 (3) |
| Dizziness | 0 | 2 (9) | 0 | 2 (3) |
| Gastroenteritis | 0 | 2 (9) | 0 | 2 (3) |
| Ligament sprain | 1 (6) | 0 | 1 (4) | 2 (3) |
| Pain in extremity | 1 (6) | 1 (4) | 0 | 2 (3) |
| Vomiting | 1 (6) | 1 (4) | 0 | 2 (3) |
| Most frequent drug‐related AE | 3 (17) | 7 (30) | 1 (4) | 11 (17) |
| Headache | 1 (6) | 2 (9) | 0 | 3 (5) |
| Diarrhea | 2 (11) | 0 | 0 | 2 (3) |
| Nausea | 1 (6) | 1 (4) | 0 | 2 (3) |
AE, adverse event; b.i.d., twice daily; t.i.d., three times daily.
a
Includes any patient given at least one dose of GSK2982772.