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Table 4 Treatment-related adverse events (experienced by ≥1 pregnant Korean women) by MedDRA primary system organ class and preferred term

From: Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women

Any treatment-related adverse event, n (%) FCM (N = 45) FS (N = 44) P value
Total number of patients 4 (9) 8 (18) 0.23
Total adverse event 9 19  
Gastrointestinal disorders
 Nausea 1 (2) 4 (9) 0.20
 Vomiting 0 (0) 2 (5) 0.24
 Constipation 0 (0) 3 (7) 0.12
 Diarrhea 0 (0) 4 (9) 0.06
 Abdominal pain upper 0 (0) 3 (7) 0.12
 Dyspepsia 0 (0) 3 (7) 0.12
Nervous system disorders
 Headache 3 (7) 0 (0) 0.24
 Dizziness 3 (7) 0 (0) 0.24
General disorders
 Fatigue 1 (2) 0 (0) 0.95
 Pyrexia 1 (2) 0 (0) 0.95
  1. According to the physician’s assessment, a single patient could appear in multiple classes. Percentages were calculated according to treatment group
  2. Fisher’s exact test was used to compare the incidence of each adverse event between study groups
  3. FCM ferric carboxymaltose, FS ferrous sulfate, MedDRA Medical Dictionary for Regulatory Activities (version 16.1)