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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