Estimated frequency of hemoglobinemia and/or hemoglobinuria following administration of anti-D IGIV for the ITP indication
| Source(s) of Data . | Reported Patients (n) . | Total Patients (n) . | Estimated Incidence Rate (%) . | Estimated Reporting Rate (%) . | Estimated Incidence . |
|---|---|---|---|---|---|
| Clinical studies | 0 | 528 | 0.0 | NA | 0 in 528 |
| Clinical trial6 | 2 | 137 | 1.5 | NA | 1 in 69 |
| FDA*/IMS21 22 | 13 | 14 500* | NA | 0.1 | 1 in 1115 |
| Source(s) of Data . | Reported Patients (n) . | Total Patients (n) . | Estimated Incidence Rate (%) . | Estimated Reporting Rate (%) . | Estimated Incidence . |
|---|---|---|---|---|---|
| Clinical studies | 0 | 528 | 0.0 | NA | 0 in 528 |
| Clinical trial6 | 2 | 137 | 1.5 | NA | 1 in 69 |
| FDA*/IMS21 22 | 13 | 14 500* | NA | 0.1 | 1 in 1115 |
Reported patients experienced hemoglobinemia and/or hemoglobinuria following anti-D IGIV administration during a specified time period. Total patients were treated or estimated to have been treated with anti-D IGIV during a specified time period. NA indicates not applicable. Data for the clinical studies are cited in references 2, 4, 6-8, 10, 11, and 23.
Data on file, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Rockville, MD; March 1995-December 1998.