Table 2.
Summary of TEAEs by Treatment Group (Safety Population)
| AE category | Treatment group | |||||
|---|---|---|---|---|---|---|
| Ferumoxytol (n = 608) | Placebo (n = 200) | Total (N = 808) | ||||
| Events, n | Patients, n (%) | Events, n | Patients, n (%) | Events, n | Patients, n (%) | |
| All TEAEs | 718 | 299 (49.2) | 206 | 86 (43.0) | 924 | 385 (47.6) |
| Treatment-related AEs | 176 | 89 (14.6) | 25 | 15 (7.5) | 201 | 104 (12.9) |
| SAEs | 23 | 16 (2.6) | 6 | 6 (3.0) | 29 | 22 (2.7) |
| Treatment-related SAEs | 4 | 4 (0.7) | 0 | 0 (0.0) | 4 | 4 (0.5) |
| Protocol-defined AEs of special interesta | 26 | 22 (3.6) | 2 | 2 (1.0) | 28 | 24 (3.0) |
| Cardiovascular AE composite endpointb | 6 | 5 (0.8) | 0 | 0 (0.0) | 6 | 5 (0.6) |
| AEs resulting in temporary discontinuation of study drug | 4 | 3 (0.5) | 0 | 0 (0.0) | 4 | 3 (0.4) |
| AEs resulting in permanent discontinuation of study drug | 17 | 12 (2.0) | 2 | 1 (0.5) | 19 | 13 (1.6) |
| AEs resulting in study discontinuation | 5 | 3 (0.5) | 3 | 2 (1.0) | 8 | 5 (0.6) |
| Death3 | 2 | 2 (0.3) | 1 | 1 (0.5) | 3 | 3 (0.4) |
| Treatment-emergent AEs reported in ≥2% of patients | ||||||
| Headache | 41 | 35 (5.8) | 13 | 12 (6.0) | 54 | 47 (5.8) |
| Nausea | 32 | 28 (4.6) | 5 | 5 (2.5) | 37 | 33 (4.1) |
| Dizziness | 28 | 24 (3.9) | 7 | 7 (3.5) | 35 | 31 (3.8) |
| Diarrhea | 20 | 17 (2.8) | 6 | 6 (3.0) | 26 | 23 (2.8) |
| Urinary tract infection | 19 | 17 (2.8) | 7 | 6 (3.0) | 26 | 23 (2.8) |
| Nasopharyngitis | 17 | 16 (2.6) | 4 | 4 (2.0) | 21 | 20 (2.5) |
| Vomiting | 15 | 13 (2.1) | 2 | 2 (1.0) | 17 | 15 (1.9) |
| Fatigue | 16 | 12 (2.0) | 3 | 3 (1.5) | 19 | 15 (1.9) |
| Rash | 12 | 12 (2.0) | 0 | 0 (0.0) | 12 | 12 (1.5) |
| Abdominal pain | 11 | 11 (1.8) | 7 | 5 (2.5) | 18 | 16 (2.0) |
| Arthralgia | 11 | 9 (1.5) | 5 | 5 (2.5) | 16 | 14 (1.7) |
| Dyspnea | 10 | 10 (1.6) | 7 | 4 (2.0) | 17 | 14 (1.7) |
| Anemia | 4 | 4 (0.7) | 4 | 4 (2.0) | 8 | 8 (1.0) |
Percentages are based on the number of patients in each treatment group and in total.
Related AEs are those classified by the investigator as related to the study drug.
a
AEs of special interest include hypotension and hypersensitivity as defined in the protocol; not all protocol-defined AEs of special interest were identified by the investigators.
b
Cardiovascular AE composite endpoint includes myocardial infarction, heart failure, moderate-to-severe hypertension, and hospitalization due to any cardiovascular cause.
c
Reported by the investigator to be unrelated to the study drug.
AE, adverse event; SAE, serious AE; TEAE, treatment-emergent AE.