|
Participants (%) with adverse or serious adverse events
|
114 (77%)
|
47 (63%)
|
|
Number of adverse events (excluding serious events)
|
316
|
157
|
|
Participants (%) with serious adverse events
|
16 (11%)
|
12 (16%)
|
|
Number of serious adverse events
|
20
|
22
|
|
Participants with hypoglycemic serious adverse events
|
3 (2%)
|
1 (1%)
|
|
Number of hypoglycemic serious adverse events
|
3
|
1
|
|
Participants (%) with hypoglycemic adverse events
|
10 (7%)
|
7 (9%)
|
|
Number of hypoglycemic adverse events
|
27
|
30
|
|
Participants (%) with device-related adverse events
|
6 (4%)
|
0
|
|
Number of device-related adverse events
|
9*
|
0
|
|
Number of adverse events leading to discontinuation
|
1
|
3
|
|
Participants (%) discontinuing due to adverse events
|
1 (1%)
|
2 (3%)
|