Table 2: Treatment-emergent adverse events experienced by ≥5% of patients in either FCM or DEX group.

MedDRA SOCa
 Preferred term
FCM
( )
(%)
DEX
( )
(%)
valueb

At Least 1 treatment-emergent adverse event60 (73.2%)59 (75.6%)0.856
Gastrointestinal disorders24 (29.3%)14 (17.9%)0.099
 Diarrhea5 (6.1%)3 (3.8%)0.720
 Nausea12 (14.6%)8 (10.3%)0.477
 Vomiting5 (6.1%)4 (5.1%)1.000
Immune system disorders08 (10.3%)0.003
 Hypersensitivity07 (9.0%)0.006
Metabolism and nutrition disorders8 (9.8%)4 (5.1%)0.371
 Hypophosphatemia7 (8.5%)00.014*
Nervous system disorders16 (19.5%)17 (21.8%)0.845
 Dizziness6 (7.3%)4 (5.1%)0.747
 Headache6 (7.3%)10 (12.8%)0.297
Skin and subcutaneous tissue disorders6 (7.3%)19 (24.4%)0.004
 Pruritus2 (2.4%)6 (7.7%)0.160
 Rash2 (2.4%)5 (6.4%)0.268
 Urticaria07 (9.0%)0.006

MedDRA: medical dictionary for regulatory activities; SOC: system organ class.
aEach subject is counted only once per SOC when multiple preferred terms are reported for the SOC.
bFrom Fisher’s exact test.
*Statistically significant at the level.
Statistically significant at the level.