| | |
80/480 mg tablet
|
Four standard tablets
|
Total*
|
60/360 mg tablet
|
Three standard tablets
|
Total**
|
|---|
|
Body system
|
Preferred term
|
N = 58
|
N = 60
|
N = 60
|
N = 57
|
N = 60
|
N = 60
|
|---|
|
n (%)
|
n (%)
|
n (%)
|
n (%)
|
n (%)
|
n (%)
|
|---|
|
Any body system
|
Total
|
1 (1.7)
|
3 (5.0)
|
4 (6.7)
|
1 (1.8)
|
4 (6.7)
|
5 (8.3)
|
|
Gastrointestinal disorders
|
Vomiting
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
|
General disorders and administrative site conditions
|
Pyrexia
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
|
Injury, poisoning and procedural complications
|
Excoriation
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
1 (1.8)
|
0 (0.0)
|
1 (1.7)
|
|
Radius fracture
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
|
Navicular bone fracture
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
|
Investigations
|
Blood creatine phosphokinase increased
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
0 (0.0)
|
1 (1.7)
|
1 (1.7)
|
|
Blood lactate dehydrogenase increased
|
1 (1.7)
|
1 (1.7)
|
2 (3.3)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
- *An overall summary for all subjects treated with 80/480 mg tablet or four standard tablets.
- **An overall summary for all subjects treated with 60/360 mg tablet or three standard tablets.
- A subject with multiple adverse events within a system organ class is counted only once in the total row.
