Table 6:
Investigator-designated infusion reactions in the safety population
| Elotuzumab flow rate ≤2 mL per min | Elotuzumab flow rate >2 mL per min | Total | |||
|---|---|---|---|---|---|
| Reaction grade 1 or 2 | Reaction grade 3 or 4 | Reaction grade 1 or 2 | Reaction grade 3 or 4 | ||
| Pyrexia | 3 | 0 | 0 | 0 | 3 |
| Nausea | 1 | 0 | 1 | 0 | 2 |
| Abdominal pain | 1 | 0 | 0 | 0 | 1 |
| Chest discomfort | 1 | 0 | 0 | 0 | 1 |
| Chills | 1 | 0 | 0 | 0 | 1 |
| Flushing | 1 | 0 | 0 | 0 | 1 |
| Hot flush | 1 | 0 | 0 | 0 | 1 |
| Hyperhidrosis | 1 | 0 | 0 | 0 | 1 |
| Pain | 1 | 0 | 0 | 0 | 1 |
| Periorbital oedema | 1 | 0 | 0 | 0 | 1 |
| Rash | 1 | 1 | 0 | 0 | 1 |
| Rash maculopapular | 1 | 0 | 0 | 0 | 1 |
Reactions are grouped by elotuzumab infusion flow rate. Adverse events listed by preferred terms as defined in the Medical Dictionary for Regulatory Activities, version 16.1.