Table 6.
Adverse events in safety set
| 1.0 ml group (N=3) | 1.5 ml group (N=3) | 2.0 ml group (N=3) | 3.0 ml group (N=3) | |||||
|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
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| No. of cases (%) | N | No. of cases (%) | N | No. of cases (%) | N | No. of cases (%) | N | |
| Adverse Events | 1 (33.3) | 3 | 1 (33.3) | 1 | 2 (66.7) | 9 | 0 (0.0) | 0 |
| Adverse Reactions | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Serious Adverse Events | 1 (33.3) | 1 | 1 (33.3) | 1 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Serious Adverse Reactions | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Adverse events leading to dislodgment | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Severity (adverse events) | 1 (33.3) | 3 | 1 (33.3) | 1 | 2 (66.7) | 9 | 0 (0.0) | 0 |
| Grade 1 | 1 (33.3) | 2 | 0 (0.0) | 0 | 2 (66.7) | 8 | 0 (0.0) | 0 |
| Grade 2 | 0 (0.0) | 0 | 0 (0.0) | 0 | 1 (33.3) | 1 | 0 (0.0) | 0 |
| Grade 3 | 1 (33.3) | 1 | 1 (33.3) | 1 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 4 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 5 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Severity (adverse reactions) | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 1 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 2 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 3 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 4 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Grade 5 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
Number of cases: the number of subjects who had an adverse event; Number: the number of adverse events that occurred. If a subject has multiple adverse events during drug administration, the number of adverse events is counted only once for the agent used, but the number of cases for the agent used is counted separately.