IRRs during all infusions
| . | Single first dose (n = 10) . | Split first dose (n = 75) . | ||||||
|---|---|---|---|---|---|---|---|---|
| First infusion . | Second infusion . | Subsequent infusions . | Total . | First infusion . | Second infusion . | Subsequent infusions . | Total . | |
| Total patients with IRR | 5 (50) | 2 (20) | 1 (10) | 6 (60) | 28 (37) | 1 (1) | 6 (8) | 32 (43) |
| Patients with an IRR | ||||||||
| Allergic rhinitis | 0 | 0 | 0 | 0 | 6 (8) | 0 | 0 | 6 (8) |
| Throat irritation | 1 (10) | 1 (10) | 0 | 1 (10) | 4 (4) | 0 | 1 (1) | 3 (4) |
| Cough | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (3) |
| Dyspnea | 0 | 0 | 0 | 0 | 3 (4) | 0 | 0 | 3 (4) |
| Nasal congestions | 0 | 0 | 0 | 0 | 2 (3) | 2 (3) | 0 | 0 |
| Wheezing | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (3) |
| Vomiting | 2 (20) | 0 | 0 | 2 (20) | 5 (7) | 0 | 1 (1) | 6 (8) |
| Nausea | 3 (30) | 2 (20) | 0 | 4 (40) | 1 (1) | 1 (1) | 1 (1) | 3 (4) |
| Abdominal discomfort | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Pyrexia | 0 | 1 (10) | 0 | 1 (10) | 1 (1) | 2 (3) | 0 | 3 (4) |
| Chills | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (3) |
| Administration site inflammation | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Feeling cold | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Hyperthermia | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Flushing | 0 | 0 | 0 | 0 | 2 (3) | 1 (1) | 0 | 3 (4) |
| Hypertension | 1 (10) | 0 | 0 | 2 (20) | 2 (3) | 0 | 0 | 2 (3) |
| Hot flush | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (3) |
| Hypotension | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Tachycardia | 0 | 0 | 1 (10) | 1 (10) | 0 | 0 | 1 (1) | 1 (1) |
| Sinus tachycardia | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Erythema | 1 (10) | 0 | 1 (10) | 1 (10) | 1 (1) | 0 | 0 | 1 (1) |
| Hyperhidrosis | 0 | 0 | 1 (10) | 1 (10) | 0 | 1 (1) | 0 | 1 (1) |
| Pruritus | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Rash | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Urticaria | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Dizziness | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Back pain | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Eyelid edema | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Nervousness | 1 (10) | 0 | 1 (10) | 1 (10) | 0 | 0 | 0 | 0 |
| . | Single first dose (n = 10) . | Split first dose (n = 75) . | ||||||
|---|---|---|---|---|---|---|---|---|
| First infusion . | Second infusion . | Subsequent infusions . | Total . | First infusion . | Second infusion . | Subsequent infusions . | Total . | |
| Total patients with IRR | 5 (50) | 2 (20) | 1 (10) | 6 (60) | 28 (37) | 1 (1) | 6 (8) | 32 (43) |
| Patients with an IRR | ||||||||
| Allergic rhinitis | 0 | 0 | 0 | 0 | 6 (8) | 0 | 0 | 6 (8) |
| Throat irritation | 1 (10) | 1 (10) | 0 | 1 (10) | 4 (4) | 0 | 1 (1) | 3 (4) |
| Cough | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (3) |
| Dyspnea | 0 | 0 | 0 | 0 | 3 (4) | 0 | 0 | 3 (4) |
| Nasal congestions | 0 | 0 | 0 | 0 | 2 (3) | 2 (3) | 0 | 0 |
| Wheezing | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (3) |
| Vomiting | 2 (20) | 0 | 0 | 2 (20) | 5 (7) | 0 | 1 (1) | 6 (8) |
| Nausea | 3 (30) | 2 (20) | 0 | 4 (40) | 1 (1) | 1 (1) | 1 (1) | 3 (4) |
| Abdominal discomfort | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Pyrexia | 0 | 1 (10) | 0 | 1 (10) | 1 (1) | 2 (3) | 0 | 3 (4) |
| Chills | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (3) |
| Administration site inflammation | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Feeling cold | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Hyperthermia | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Flushing | 0 | 0 | 0 | 0 | 2 (3) | 1 (1) | 0 | 3 (4) |
| Hypertension | 1 (10) | 0 | 0 | 2 (20) | 2 (3) | 0 | 0 | 2 (3) |
| Hot flush | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (3) |
| Hypotension | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Tachycardia | 0 | 0 | 1 (10) | 1 (10) | 0 | 0 | 1 (1) | 1 (1) |
| Sinus tachycardia | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Erythema | 1 (10) | 0 | 1 (10) | 1 (10) | 1 (1) | 0 | 0 | 1 (1) |
| Hyperhidrosis | 0 | 0 | 1 (10) | 1 (10) | 0 | 1 (1) | 0 | 1 (1) |
| Pruritus | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Rash | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Urticaria | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Dizziness | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Back pain | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Eyelid edema | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (1) |
| Nervousness | 1 (10) | 0 | 1 (10) | 1 (10) | 0 | 0 | 0 | 0 |
All data are n (%).