Table 4.
Percentage of patients with adverse events at the injection site | Treatment group |
|||
---|---|---|---|---|
Fosaprepitant (n = 174) |
Placebo (n = 170) |
|||
n | Percentage | n | Percentage | |
Overall | 41 | 23.6 | 21 | 12.4 |
Erythema | 9 | 5.2 | 9 | 5.3 |
Induration | 1 | 0.6 | 1 | 0.6 |
Pain | 27 | 15.5 | 11 | 6.5 |
Swelling | 6 | 3.4 | 5 | 2.9 |
Phlebitis | 4 | 2.3 | 4 | 2.4 |
Pruritus | 1 | 0.6 | 0 | 0.0 |
Reaction | 1 | 0.6 | 2 | 1.2 |
Extravasation | 3 | 1.7 | 0 | 0.0 |
Discolouration | 1 | 0.6 | 0 | 0.0 |
Adverse events reported by the investigator were coded using MedDRA/J Version 12.1.
In addition to ‘infusion-site pain’, ‘infusion-site erythema’, ‘infusion-site induration’, and ‘thrombophlebitis’ defined in the protocol, adverse events observed at the infusion site and in blood vessels at the infusion site are listed.