Table 1.
Descriptive data of acute myeloid leukemia patients prescribed Gemtuzumab Ozogamycin (GO) in an academic pharmacovigilance initiative and a sponsor supported prospective registry of routine clinical practice.
| Academic registry |
Sponsor supported registry |
|
|---|---|---|
| Number of individual cases | 99 | 44 |
| Age (years) mean | – ** | 61.5 |
| Participating medical centers |
60 | 54 |
| Overall incidence (%) | Not reported | 9.1 |
| Incidence with concomitant drug use (%) |
7 | Not reported |
| Deaths among SOS patients (%)a |
66 | 30 |
| Hospitalized (%) | 80 | Not reported |
| Autologous SCT SOS incidence (%) |
16 | Not reported |
| Allogeneic SCT SOS incidence (%) |
38 | Not reported |
| Median time from GO administration to SOS occurrence (allogeneic) |
10 days | Not reported |
| Median time from GO administration to SOS occurrence (post-SCT) |
13 days | Not reported |
| Median time to peak bilirubin |
– ** | 2 weeks |
| Risk factors (multivariate analyses) |
Not conducted | None identified |
| Data/literature published | 2003, 2007 | 2003, 2007, 2013 |
| Voluntary removal of drug from market |
2010 |
SCT = Stem cell transplant.
a
Exact two-tailed p < 0.034.