Table 2:
Treatment-emergent adverse events
Part A: schedule 1 (n=6) |
Part A: schedule 2 (n=6) |
Part A: schedule 3 (n=6) |
Part B (n=25) |
Overall study cohort (n=43) |
||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1–2 | Grade 3 |
Grade 4 |
Grade 5 |
Grade 1–2 | Grade 3 |
Grade 4 |
Grade 5 |
Grade 1–2 | Grade 3 |
Grade 4 |
Grade 5 |
Grade 1–2 | Grade 3 |
Grade 4 |
Grade 5 |
Grade 1–2 | Grade 3 |
Grade 4 |
Grade 5 |
|
Fatigue | 1 (17%) | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 4 (67%) | 0 | 0 | 0 | 20 (80%) | 0 | 0 | 0 | 26 (60%) | 0 | 0 | 0 |
Nausea | 2 (33%) | 0 | 0 | 0 | 2 (33%) | 0 | 0 | 0 | 4 (67%) | 0 | 0 | 0 | 9 (36%) | 0 | 0 | 0 | 17 (40%) | 0 | 0 | 0 |
Joint pain or arthritis | 2 (33%) | 0 | 0 | 0 | 1 (17%) | 1 (17) | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 9 (36%) | 0 | 0 | 0 | 13 (30%) | 1 (2%) | 0 | 0 |
Decreased appetite | 2 (33%) | 0 | 0 | 0 | 2 (33%) | 0 | 0 | 0 | 3 (50%) | 0 | 0 | 0 | 3 (12%) | 0 | 0 | 0 | 10 (23%) | 0 | 0 | 0 |
Xerostomia | 2 (33%) | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 6 (24%) | 0 | 0 | 0 | 9 (21%) | 0 | 0 | 0 |
Diarrhoea | 0 | 0 | 0 | 0 | 2 (33%) | 0 | 0 | 0 | 2 (33%) | 0 | 0 | 0 | 5 (20%) | 0 | 0 | 0 | 7 (16%) | 0 | 0 | 0 |
Hypothyroidism | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 (20%) | 0 | 0 | 0 | 6 (14%) | 0 | 0 | 0 |
Rash | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4%) | 0 | 0 | 0 | 3 (7%) | 0 | 0 | 0 |
Pruritus | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 1 (4%) | 0 | 0 | 0 | 3 (7%) | 0 | 0 | 0 |
Dry eyes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (12%) | 0 | 0 | 0 | 3 (7%) | 0 | 0 | 0 |
Vomiting | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4) | 0 | 0 | 0 | 2 (5%) | 0 | 0 | 0 |
Pneumonitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 1 (4%) | 0 | 0 | 0 | 1 (2%) | 1 (2%) | 0 | 0 |
Thrombocytopenia | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Anaemia | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Neutropenia | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Data are n (%).