Anemia

Anemia / 2012 / Article / Tab 2

Clinical Study

Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials

Table 2

Incidence of treatment-emergent adverse events occurring in ≥2% of subjects.

Single-dose study
value
FCM
SMC

≥1 event132 (36.0)128 (34.6)
Nausea15 (4.1)18 (4.9)0.722
Headache11 (3.0)5 (1.4)0.138
Diarrhea10 (2.7)8 (2.2)0.642
Fatigue10 (2.7)7 (1.9)0.474
Constipation7 (1.9)13 (3.5)0.257
Vomiting4 (1.1)14 (3.8) 0.029*
Abdominal pain2 (<1)8 (2.2)0.107
Urinary tract infection1 (<1)8 (2.2) 0.038*

Multidose study
FCM SMC



≥1 event185 (54.4)198 (55.0)
Decreased blood phosphorous25 (7.3)0<0.001**
Headache16 (4.7)18 (5.0)0.862
Nausea14 (4.1)27 (7.5)0.055
Constipation12 (3.5)26 (7.2)0.031*
Diarrhea10 (2.9)14 (3.9)0.537
Dizziness10 (2.9)17 (4.7)0.242
Upper respiratory tract infection9 (2.6)6 (1.7)0.440
Arthralgia8 (2.3)8 (2.2)1.000
Myalgia8 (2.3)2 (0.06)0.058
Pain in extremity9 (2.6)4 (1.1)0.167
Fatigue9 (2.6)5 (1.4)0.287
Increased alanine aminotrasferase7 (2.0)5 (1/4)0.570
Back pain7 (2.0)6 (1.7)0.784
Nasopharyngitis7 (2.0)6 (1.7)0.784
Urinary tract infection7 (2.0)6 (1.7)0.784
Vomiting6 (1.7)13 (3.6)0.164
Peripheral edema3 (<1)8 (2.2)0.224
Cough2 (<1)8 (2.2)0.108

Values are expressed as number of subjects (percentage).
FCM: ferric carboxymaltose; SMC: standard medical care.
*Statistically significant at 0.05 level.
**Statistically significant at 0.001 level.

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