Table 3.
Patients With AEs at the Infusion Site | AEsa | Treatment‐Related AEsa | ||||
---|---|---|---|---|---|---|
Placebo N = 193 | Fosnetupitant at a Dose of 81 mg N = 194 | Fosnetupitant at a Dose of 235 mg N = 191 | Placebo N = 193 | Fosnetupitant at a Dose of 81 mg N = 194 | Fosnetupitant at Dose of 235 mg N = 191 | |
Total ISRs | 11 (5.7) | 21 (10.8) | 15 (7.9) | 0 (0.0) | 1 (0.5) | 2 (1.0) |
Injection site pain | 8 (4.1) | 14 (7.2) | 11 (5.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Injection site erythema | 5 (2.6) | 3 (1.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Injection site induration | 3 (1.6) | 2 (1.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Injection site thrombophlebitis | 0 (0.0) | 3 (1.5) | 3 (1.6) | 0 (0.0) | 1 (0.5) | 1 (0.5) |
Injection site reaction | 0 (0.0) | 2 (1.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Injection site discomfort | 0 (0.0) | 0 (0.0) | 1 (0.5) | 0 (0.0) | 0 (0.0) | 1 (0.5) |
Abbreviations: AE, adverse event; ISR, infusion site reaction.
Data are shown as the number of patients (%).
Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03).