Table 3.
Post-marketing surveillance conducted in Japan
| Study name | Period | n | No. cases ILD (%) | No. ILD-related deaths (%) |
|---|---|---|---|---|
| Cancer clinical study groups | ||||
| WJTOG†27 | 2002/8-2002/12 | 1976 | 64 (3.2) | 25 (1.3) |
| National Cancer Center28 | 2002/7-2002/12 | 112 | 6 (5.4) | 4 (3.6) |
| OLCSG††29 | 2000/11-2003/10 | 325 | 22(6.8) | 10(3.1) |
| JMTO†††30 | 2002/7-2003/2 | 399 | 33 (8.3) | 17 (4.3) |
| Total | 2812 | 125(4.4) | 56(2.0) | |
| Sponsored by AstraZeneca | ||||
| EPPV*16 | 2002/7-2003/1 | 22,000** | 449 (2.0) | 161 (0.7) |
| ADR monitoring20 | 2002/7-2003/7 | 35,000** | 723 (2.1) | 285 (0.8) |
| ADR monitoring22 | 2002/7-2003/12 | 50,000** | 864 (1.7) | 354 (0.7) |
| Total | 50,000** | 864 (1.7) | 354 (0.7) | |
| Mandatory total surveillance6 | 2003/6-2003/12 | 3322 | 193 (5.8) | 75 (2.3) |
†
The West Japan Thoracic Oncology Group
††
The Okayama Lung Cancer Study Group
†††
The Japan-Multinational Trial Organization
*
EPPV: Early Post-marketing Pharmacovigilance. In Japan, in addition to routine post-marketing safety reporting, an EPPV is required for all new and supplementary new drug applications. An EPPV requires a sponsor to collect ADR for the first six months post launch of a new drug or a new indication. This is done through intensive monitoring and solicited prospective requests by the sponsor to physicians in Japan via Dear Doctor letters.
**
Number estimated from volume of sales (later the number was corrected).