Table 4.
Summary of the key clinical trials for invasive aspergillosis
| Voriconazole versus conventional amphotericin B12 | Voriconazole versus combination (anidulafungin)18 | Voriconazole versus isavuconazole19 | Voriconazole versus posaconazole20 | Mean | |
|---|---|---|---|---|---|
| Duration | July 1997–October 2000 | July 2008–May 2011 | March 2007–March 2013a | October 2013–September 2019 | — |
| Duration, months | 40 | 35 | 73a | 72 | 55 |
| Patients assessed, n | 391 | 459 | 532 | 653 | 509 |
| Patients in ITT, n | 391 (197 versus 194) | 422 (207 versus 215) | 516 (258 versus 258) | 575 (288 versus 287) | — |
| Sites, n | 95 | 93 | 102 | 91 | 95 |
| Countries, n | 19 | 24 | 26 | 26 | 23 |
| Mean patients in ITT per site, n | 4.1 | 4.5 | 5.1 | 6.3 | 5 |
| FDA approval | 24 May 2002 | Not applicable | 6 March 2015 | June 2021 | 1.5–2 years later |
aTrial was suspended from January 2009–March 2011.
ITT, intention-to-treat.