• The total number of adverse reactions (ARs) was 158 (a rate of 0.20 ARs per infusion)
  • Fifty-eight subjects (98%) had an adverse reaction during the study. The proportion of subjects who had at least one adverse reaction was similar for both the 3- and 4-week cycles. The most common adverse reactions observed in this clinical trial were headache (22 subjects, 37%), sinusitis (16 subjects, 27%), diarrhea (14 subjects, 23%), gastroenteritis viral (13 subjects, 22%), nasopharyngitis (13 subjects, 22%), upper respiratory tract infection (13 subjects, 22%), bronchitis (12 subjects, 20%), nausea (12 subjects, 20%), and acute sinusitis (11 subjects, 19%)

Adverse reactions (within 72 hours after the end of an ASCENIV™ infusion) in ≥5% of subjects

Adverse Reactions Number (%) of Subjects (N=59) Number (%) of Infusions (N=793)
Headache 14 (24) 21 (2.6)
Sinusitis 6 (10) 7 (0.9)
Nausea 5 (9) 5 (0.6)
Acute sinusitis 4 (7) 4 (0.5)
Fatigue 4 (7) 9 (1.1)
Muscle spasms 4 (7) 4 (0.5)
Bronchitis 3 (5) 3 (0.4)
Diarrhea 3 (5) 3 (0.4)
Nose bleed 3 (5) 4 (0.5)
Muscle pain 3 (5) 5 (0.6)
Oropharyngeal pain 3 (5) 3 (0.4)
Pain in extremity 3 (5) 3 (0.4)
Itching 3 (5) 3 (0.4)
  • No study drug–related serious adverse events (SAEs) were reported, although 2 SAEs (postoperative wound infection and migraine) were documented2