Table 7 Adverse events (ITT)
N. of patients (%) | N. of events | |
|---|---|---|
N. (%) of patients with any AE | 10 (3.4 %) | 13 |
SAE | 1 (0.3 %) | 1 |
Criterion for SAE | ||
Life-threatening | 1 (0.3 %) | 1 |
Intensity | ||
Mild | 8 (2.7 %) | 11 |
Moderate | 1 (0.3 %) | 1 |
Severe | 1 (0.3 %) | 1 |
Treatment/corrective therapy | ||
No | 8 (2.7 %) | 11 |
Yes | 2 (0.7 %) | 2 |
Related with investigation BGM technical complaint | ||
Yes (serious) | 1 (0.3 %) | 1 |
N. of patients without any AE | 282 (96.6 %) | |
Total of available patients | 292 (100 %) | |