Table 3.
Expected incidence of adverse drug reaction | Number of patients to be observed to detect: | ||
---|---|---|---|
1 event | 2 events | 3 events | |
1:100 | 300 | 480 | 650 |
1:200 | 600 | 960 | 1300 |
1:1000 | 3000 | 4800 | 6500 |
1:2000 | 6000 | 9600 | 13 000 |
1:10 000 | 30 000 | 48 000 | 65 000 |