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Table 3 Treatment-emergent AEs and incidence of Treatment-emergent AEs occurring in ≥2 % of patients (safety population)

From: Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia

  Ferumoxytol Treatment Group (n = 486) Iron Sucrose Treatment Group (n = 281) Total (N = 767)
AE Summary
All AEs 206 (42.4) 141 (50.2) 347 (45.2)
Treatment-related AEs 66 (13.6) 45 (16.0) 111 (14.5)
SAEs 24 (4.9) 11 (3.9) 35 (4.6)
Treatment-related SAEs 3 (0.6) 1 (0.4) 4 (0.5)
AEs of Special Interesta 12 (2.5) 15 (5.3) 27 (3.5)
Cardiovascular AEsb 6 (1.2) 3 (1.1) 9 (1.2)
AEs resulting in temporary discontinuation of study drug 3 (0.6) 4 (1.4) 7 (0.9)
AEs resulting in permanent discontinuation of study drug 7 (1.4) 9 (3.2) 16 (2.1)
AEs resulting in study discontinuation 4 (0.8) 6 (2.1) 10 (1.3)
Death 1 (0.2) 0 (0.0) 1 (0.1)
Treatment-emergent AEs occurring in ≥2 % of patients in any treatment group by decreasing incidence in the Ferumoxytol Treatment Group
Headache 22 (4.5) 13 (4.6) 35 (4.6)
Nausea 17 (3.5) 10 (3.6) 27 (3.5)
Dizziness 10 (2.1) 5 (1.5) 15 (2.0)
Dysgeusia 10 (2.1) 14 (5.0) 24 (3.1)
Peripheral edema 5 (1.0) 8 (2.8) 13 (1.7)
Urinary tract infection 5 (1.0) 9 (3.2) 14 (1.8)
Muscle spasms 5 (1.0) 6 (2.1) 11 (1.4)
Vomiting 4 (0.8) 6 (2.1) 10 (1.3)
Hypotension 3 (0.6) 10 (3.6) 13 (1.7)
Pyrexia 2 (0.4) 7 (2.5) 9 (1.2)
  1. Data are presented as n (%). AE: adverse event; SAE: serious adverse event
  2. aIncludes hypotension and hypersensitivity
  3. bIncludes myocardial infarction, heart failure, moderate to severe hypertension, and hospitalization due to any cardiovascular cause