Table 6.
Summary of adverse events
| Adverse event | Drug-related* adverse event | ||
|---|---|---|---|
| SAD study (n=67) | |||
| 10 mg (n=6) | 2 (2) | 1 (1) | Back pain |
| 25 mg (n=6) | 2 (1) | 2 (1) | Nasal congestion, sneezing |
| 50 mg (n=8) | 2 (1) | – | |
| 100 mg (n=8) | 2 (1) | 2 (1) | Flushing, headache |
| 200 mg (n=8) | 6 (3) | 6 (3) | Diarrhea, feeling hot, headache, nasal congestion, rhinorrhea, throat irritation |
| 400 mg (n=8) | – | – | |
| 600 mg (n=8) | 1 (1) | – | |
| Placebo (n=14) | 2 (2) | 2 (2) | Musculoskeletal chest pain, oropharyngeal pain |
| Subtotal | 17 (11) | 13 (8) | |
| MAD study (n=58) | |||
| 100 mg (n=8) | 2 (1) | 1 (1) | Hematochezia |
| 200 mg (n=8) | – | – | |
| 400 mg (n=8) | 2 (2) | – | |
| 600 mg (n=8) | 6 (5) | 5 (4) | Diarrhea, flatulence, lip ulceration, nausea, fatigue |
| 800 mg (n=6) | 1 (1) | – | |
| Febuxostat 80 mg (n=8) | 5 (3) | 5 (3) | Lip blister, lip swelling, loose stool, headache, dermatitis acneiform |
| Placebo (n=10) | 4 (3) | 2 (1) | Diarrhea, dizziness |
| Subtotal | 20 (15) | 13 (9) | |
Notes: All values are presented as number of adverse events (number of subjects with adverse events).
*
The adverse event was counted as drug related when its causality assessment was certain, probable, or possible.
Abbreviations: SAD, single ascending dose; MAD, multiple ascending dose.