Table 5. Grade 3-4 adverse events and patients who discontinued treatment due to an adverse event, by dose cohort.
| Adverse Event | Dosage, mg/day | |||||||
|---|---|---|---|---|---|---|---|---|
| 30 (n = 3) |
60 (n = 27) |
150 (n = 28) |
240 (n = 29) |
360 (n = 28) |
480 (n = 22) |
600 (n = 3) |
Total (n = 140) |
|
| Grade 3-4 Adverse Events Occurring in More Than 2 Patients | ||||||||
| Fatigue | - | - | - | 5 (17%) | 6 (21%) | 5 (23%) | - | 16 (11%) |
| Anaemia | - | 2 (7%) | 1 (4%) | - | 1 (4%) | - | - | 4 (3%) |
| Arthralgia | - | 2 (7%) | - | - | - | 1 (5%) | - | 3 (2%) |
| Asthenia | - | - | - | - | 2 (7%) | 1 (5%) | - | 3 (2%) |
| Convulsions | - | - | - | - | 2 (9%)a | 1 (33%) | 3 (2%) | |
| Adverse Events Leading to Discontinuation of Treatment | ||||||||
| Seizure | - | - | - | - | 1 (4%) | 1 (5%) | 1 (33%) | 3 (2%) |
| Rash | - | - | - | - | - | 1 (5%) | 1 (33%) | 2 (1%) |
| Nausea/Vomiting | - | - | - | - | - | 1 (5%) | - | 1 (1%) |
| Fatigue | - | - | - | 1 (3%) | - | - | - | 1 (1%) |
| Myocardial infarction | - | - | - | - | 1 (4%) | - | - | 1 (1%) |
a
One patient had convulsion after dose reduction to 360 mg/day