Table 2.
Summary of Adverse Events Occurring or Worsening On or After the First Dose of Study Medication Up to 14 Days After the Last Dose (safety population)
| Patients With Adverse Events, n (%) | Ferric Maltol (n = 127) | IV Ferric Carboxymaltose (n = 120) |
|---|---|---|
| TEAE | 75 (59) | 43 (36) |
| TESAE | 12 (9) | 4 (3) |
| Death | 1 (<1) | 0 |
| Treatment-related TEAE | 25 (20) | 7 (6) |
| Treatment-related TESAE | 0 | 0 |
| TEAE leading to discontinuation | 13 (10) | 3 (3) |
| TEAEs in ≥2% of patients | ||
| Abdominal pain | 12 (9) | 3 (3) |
| Nausea | 6 (5) | 2 (2) |
| Abdominal pain upper | 7 (6) | 2 (2) |
| Ulcerative colitis flare | 4 (3) | 4 (3) |
| Crohn disease flare | 3 (2) | 4 (3) |
| Diarrhea | 6 (5) | 1 (<1) |
| Constipation | 5 (4) | 1 (<1) |
| Feces discolored | 4 (3) | 0 |
| Flatulence | 4 (3) | 0 |
| Vomiting | 1 (<1) | 3 (3) |
| Nasopharyngitis | 10 (8) | 4 (3) |
| Upper respiratory tract infection | 1 (<1) | 3 (3) |
| Urinary tract infection | 2 (2) | 2 (2) |
| Pyrexia | 1 (<1) | 4 (3) |
| Asthenia | 3 (2) | 1 (<1) |
| Headache | 4 (3) | 1 (<1) |
| Arthralgia | 4 (3) | 1 (<1) |
TESAE indicates treatment-emergent serious adverse event.