Table 4.

IRRs during all infusions

Single first dose (n = 10)Split first dose (n = 75)
First infusionSecond infusionSubsequent infusionsTotalFirst infusionSecond infusionSubsequent infusionsTotal
Total patients with IRR5 (50)2 (20)1 (10)6 (60)28 (37)1 (1)6 (8)32 (43)
Patients with an IRR
 Allergic rhinitis00006 (8)006 (8)
 Throat irritation1 (10)1 (10)01 (10)4 (4)01 (1)3 (4)
 Cough00002 (3)002 (3)
 Dyspnea00003 (4)003 (4)
 Nasal congestions00002 (3)2 (3)00
 Wheezing00001 (1)001 (3)
 Vomiting2 (20)002 (20)5 (7)01 (1)6 (8)
 Nausea3 (30)2 (20)04 (40)1 (1)1 (1)1 (1)3 (4)
 Abdominal discomfort00001 (1)001 (1)
 Pyrexia01 (10)01 (10)1 (1)2 (3)03 (4)
 Chills00002 (3)002 (3)
 Administration site inflammation00001 (1)001 (1)
 Feeling cold00001 (1)001 (1)
 Hyperthermia00001 (1)001 (1)
 Flushing00002 (3)1 (1)03 (4)
 Hypertension1 (10)002 (20)2 (3)002 (3)
 Hot flush00002 (3)002 (3)
 Hypotension00001 (1)001 (1)
 Tachycardia001 (10)1 (10)001 (1)1 (1)
 Sinus tachycardia00001 (1)001 (1)
 Erythema1 (10)01 (10)1 (10)1 (1)001 (1)
 Hyperhidrosis001 (10)1 (10)01 (1)01 (1)
 Pruritus00001 (1)001 (1)
 Rash00001 (1)001 (1)
 Urticaria00001 (1)001 (1)
 Dizziness00001 (1)001 (1)
 Back pain00001 (1)001 (1)
 Eyelid edema00001 (1)001 (1)
 Nervousness1 (10)01 (10)1 (10)0000
  • All data are n (%).