Table 2 Summary of AEs and AEs experienced by more than one participant across any treatment group (safety population)
SOC | GSK3036656 (ganfeborole) | ||||
|---|---|---|---|---|---|
Event | N = 18 | 1 mg | 5 mg | 15 mg | 30 mg |
N = 9 | N = 17 | N = 16 | N = 15 | ||
Any AE, n (%) | 14 (78) | 7 (78) | 14 (82) | 15 (94) | 9 (60) |
Grade 1 | 10 (56) | 6 (67) | 11 (65) | 12 (75) | 9 (60) |
Grade 2 | 4 (22) | 1 (11) | 3 (18) | 3 (19) | 0 |
Grade 3 | 0 | 0 | 0 | 0 | 0 |
SAE, n (%) | 0 | 0 | 0 | 0 | 0 |
AE leading to withdrawal from study treatment, n (%) | 0 | 0 | 1 (6) | 1 (6) | 0 |
AE leading to withdrawal from study, n (%) | 0 | 0 | 0 | 0 | 0 |
Drug-related AE, n (%) | 5 (28) | 4 (44) | 4 (24) | 5 (31) | 2 (13) |
AEs experienced by more than one participant across any treatment groups | |||||
Gastrointestinal disorders | |||||
Abdominal pain | 3 (17) | 0 | 0 | 0 | 2 (13) |
Nausea | 2 (11) | 0 | 0 | 2 (13) | 0 |
Diarrhea | 1 (6) | 0 | 2 (12) | 0 | 0 |
Dyspepsia | 0 | 1 (11) | 1 (6) | 1 (6) | 1 (7) |
Vomiting | 0 | 0 | 1 (6) | 1 (6) | 2 (13) |
Nervous system disorders | |||||
Headache | 3 (17) | 2 (22) | 1 (6) | 2 (13) | 1 (7) |
Dizziness | 2 (11) | 1 (11) | 1 (6) | 1 (6) | 0 |
Skin and subcutaneous tissue disorders | |||||
Pruritus | 2 (11) | 2 (22) | 1 (6) | 4 (25) | 0 |
Rash pruritic | 2 (11) | 1 (11) | 0 | 0 | 1 (7) |
Rash papular | 1 (6) | 0 | 0 | 2 (13) | 0 |
Skin hypopigmentation | 1 (6) | 0 | 0 | 0 | 1 (7) |
Musculoskeletal and connective tissue disorders | |||||
Arthralgia | 2 (11) | 0 | 1 (6) | 4 (25) | 0 |
Myalgia | 1 (6) | 1 (11) | 0 | 2 (13) | 0 |
Respiratory, thoracic and mediastinal disorders | |||||
Hemoptysis | 2 (11) | 0 | 5 (29) | 2 (13) | 1 (7) |
Pleuritic pain | 1 (6) | 0 | 2 (12) | 1 (6) | 0 |
Blood and lymphatic system disorders | |||||
Neutropenia | 0 | 0 | 2 (12) | 0 | 0 |
Eye disorders | |||||
Eye irritation | 0 | 0 | 0 | 1 (6) | 1 (7) |
