Event Type | Number of Events | % of Subjects with events (n = 99)a |
---|---|---|
Total number of events | 115 | 42.4% |
Serious/ SAE | 12 | 8.1% |
Non-Serious/AE | 103 | 41.4% |
Related to Device | 4 | 4.0% |
Serious/ SAE | 0a | 0.0% |
Non-Serious/ AE | 4 | 4.0% |
Related to Procedure | 87 | 36.4% |
Serious/ SAE | 7b | 5.1% |
Non-Serious/ AE | 80 | 34.3% |