Clinical Study
Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
Table 3
Subjects who experienced serious adverse events.
| Subject | Age/sex | Event | Severity | Causality |
| FCM | 1 | 63/M | Syncope | Grade 4 | None | Asthenia | Grade 4 | None | 2 | 54/F | Abdominal pain | Grade 2 | None | 3 | 76/M | Crohn’s disease | Grade 3 | Unlikely | Death | Grade 5 | Unlikely | 4 | 83/F | Syncope | Grade 3 | None | 5 | 53/M | Colon cancer recurrent | Grade 4 | None |
| DEX | 1 | 32/F | Hypersensitivity | Grade 4 | Probable | Atrial fibrillation | Grade 2 | Probable | 2 | 56/F | Vascular pseudoaneurysm | Grade 3 | None | 3 | 64/F | Anaphylactic reaction | Grade 4 | Probable |
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