Table 2 Description of reporting targets of suspected Adverse Events by type of sponsors
National sponsors | International sponsors | |
|---|---|---|
When to report adverse events | Frequency | Frequency |
Serious adverse events | ||
No later than 1 hour | 0 | 0 |
No later than 24 hours | 0 | 31 |
No later than 7 days | 1 | 2 |
No later than 15 days | 0 | 1 |
Others | 0 | 5 |
Did not specify | 30 | 32 |
Total | 31 | 71 |
Unexpected adverse events | ||
No later than 1 hour | 0 | 1 |
No later than 24 hours | 0 | 12 |
No later than 7 days | 1 | 1 |
No later than 15 days | 0 | 3 |
Others | 0 | 6 |
Did not specify | 30 | 48 |
Total | 31 | 71 |