Table 3.
Overview of the hypersensitivity reactions (HSRs) in patients treated with ferric carboxymaltose or iron isomaltoside‐1000, overall, and by Ring and Messmer classification, time to occurrence and Naranjo score
| Ferric carboxymaltose (n = 836) | Iron isomaltoside‐1000 (n = 496) | RR (95% CI) | |
|---|---|---|---|
| Total no. of HSRs | 18 | 43 | |
| Risk on HSR (95% CI) | 2.1% (1.1–3.2%) | 8.7% (6.1–11.2%) | 0.248 (0.145–0.426) P < 0.0001 |
| Ring and Messmer classification a | |||
| Grade I | 12 (66.7%) | 11 (25.6%) | 0.647 (0.289–1.456) |
| Grade II | 6 (33.3%) | 29 (67.4%) | 0.123 (0.051–0.294) |
| Grade III | ‐ | 3 (6.9%) | n.a. |
| Time to occurrence | |||
| < 5 min | 2 (11.1%) | 14 (32.6%) | 0.085 (0.019–0.371) |
| 5–30 min | 4 (22.2%) | 15 (34.9%) | 0.158 (0.053–0.474) |
| > 30 min | 4 (22.2%) | 12 (27.9%) | 0.198 (0.064–0.610) |
| Unknown | 8 (44.4%) | 2 (4.7%) | 2.373 (0.506–11.13) |
| Naranjo Score | |||
| Definite HSR | ‐ | ‐ | n.a. |
| Probable HSR | 18 (100%) | 43 (100%) | n.a. |
| Possible HSR | ‐ | ‐ | n.a. |
| Doubtful HSR | ‐ | ‐ | n.a. |
n.a., not applicable; RR, Relative Risk; P‐value of <0.0125 indicates statistical significance; HSR, hypersensitivity reaction
a
No grade IV reactions occurred