Table 2.
Pulmonary SAE and pulmonary SAE-related deaths reported from clinical trials conducted in Japan and other countries before approval of gefitinib2
| Study name | Phase | Study period | Participating nation/s | n | No. cases of pulmonary SAE* | No. deaths |
|---|---|---|---|---|---|---|
| I | 1998/8-2001/3 | Japan | 31 | 0 | 0 | |
| I | 1998/4-2001/1 | USA, Britain | 64 | 13 | 2 | |
| I/II | 1999/2-2000/8 | Europe | 88 | 4 | 1 | |
| I/II | 1999/4-2000/10 | USA | 69 | 12 | 5 | |
| IDEAL1 | II | 2000/10-2001/1 | Japan, Europe, etc. | 209 | 22 | 4 |
| IDEAL2 | II | 2000/11-2001/4 | USA | 216 | 39 | 5 |
| Total | 677 | 90 | 17 (2.5%) |
*
More than one SAE may have occurred per patient.