Table 3 Summary of treatment-emergent adverse events (TEAEs) with reasonable causal relationship with the injection procedure or intravitreal aflibercept (IVT-AFL) treatment in the treatment-naïve and non-treatment-naïve patient cohorts. TEAEs are stratified by injector, where the same category of injector has administered IVT-AFL injections throughout the study or where the same injector category has administered IVT-AFL 75% of all injections throughout the study. The Other HCP injector group includes all non-clinician healthcare professionals (HCPs), including nurses and optometrists. Analysis was conducted in the safety population.
Injector role | Injection procedure-related TEAEs | IVT-AFL treatment-related TEAEs | ||||||
|---|---|---|---|---|---|---|---|---|
TEAEs n | Patients n (%) | Injections by injector role associated with TEAE (%) | TEAEs n | Patients n (%) | Injections by injector role associated with TEAE (%) | |||
Treatment-naïve (n = 507) | Any TEAE (n = 711) | |||||||
All TEAEs/All injector roles | 44 | 28 (5.5) | 1.1 | 26 | 16 (3.2) | 0.6 | ||
Administrator of the last injection prior to TEAE | Doctor | 27 | 14 (2.8) | 1.6 | 14 | 8 (1.6) | 0.8 | |
Other HCP | 17 | 14 (2.8) | 0.7 | 12 | 8 (1.6) | 0.5 | ||
Same injector role for 100% injections | Doctor | 1 | 1 (0.2) | 0.2 | 1 | 1 (0.2) | 0.2 | |
Other HCP | 3 | 3 (0.6) | 0.4 | 1 | 1 (0.2) | 0.1 | ||
Same injector role for 75% injections | Doctor | 11 | 6 (1.2) | 1.1 | 7 | 5 (1.0) | 0.7 | |
Other HCP | 12 | 8 (1.6) | 0.8 | 8 | 4 (0.8) | 0.5 | ||
Non-treatment-naïve (n = 241) | Any TEAE (n = 237) | |||||||
All TEAEs/All injector roles | 13 | 10 (4.1) | 0.8 | 9 | 6 (2.5) | 0.5 | ||
Administrator of the last injection prior to TEAE | Doctor | 5 | 5 (2.1) | 0.7 | 4 | 3 (1.3) | 0.5 | |
Other HCP | 8 | 5 (2.1) | 0.7 | 5 | 3 (1.3) | 0.4 | ||
Same injector role for 100% injections | Doctor | 2 | 2 (0.8) | 0.7 | 1 | 1 (0.4) | 0.3 | |
Other HCP | 2 | 1 (0.4) | 0.7 | 2 | 1 (0.4) | 0.7 | ||
Same injector role for 75% injections | Doctor | 3 | 3 (1.2) | 0.7 | 1 | 1 (0.4) | 0.2 | |
Other HCP | 6 | 3 (1.2) | 1.0 | 6 | 3 (1.2) | 1.0 | ||
