Adverse events profile (SAF).

*p-values calculated by χ2-test except for severe TEAEs and nausea (Fisher’s exact test);
†TEAEs with a temporal relationship to the study drug administration if no other drug, therapeutic intervention or underlying condition provides a sufficient explanation for the observed event.
Three mild cases of urticaria that were considered FCM-related resolved without medication. Among the five patients that experienced one or more severe TEAEs, one patient had nausea, heavy legs, headache, arthralgia and myalgia, one patient had hematoma and two times discoloration at injection sites, and three patients had one severe TEAE each (headache, cough and night sweat, respectively).
TEAE treatment emergent adverse event; SAE serious adverse event; n.s. not significant.