Summary of 1-year incidence of targeted non-ocular events
| Number of non-ocular events of particular interest (%) | WAVE Germany N=3470 | HELIOS Netherlands N=243 | HELIOS Belgium N=260 | Sweden N=471 | Total N=4444 |
|---|---|---|---|---|---|
| Non-cardiac arterial thromboembolic events | |||||
| Stroke*† | 17 (0.49) | 1 (0.41) | 0 | 1 (0.21) | 19 (0.43) |
| Transient ischaemic attack | 2 (0.06) | 0 | 2 (0.77) | 1 (0.21) | 5 (0.11) |
| Other arterial thromboembolic events‡ | 1 (0.03) | 0 | 1 (0.38) | 0 | 2 (0.05) |
| Hypersensitivity | 4 (0.12) | 2 (0.82) | 2 (0.77) | 0 | 8 (0.18) |
| Hypertension | 4 (0.12) | 0 | 3 (1.15) | 0 | 7 (0.16) |
| Myocardial infarction | 4 (0.12) | 1 (0.41) | 0 | 0 | 5 (0.11) |
| Non-ocular haemorrhage† | 3 (0.09) | 1 (0.41) | 0 | 1 (0.21) | 5 (0.11) |
| Venous thromboembolic events | 3 (0.09) | 0 | 1 (0.38) | 0 | 4 (0.09) |
| Any non-ocular event of particular interest | 55 (1.24) | ||||
*Includes the terms cerebral haemorrhage, cerebral infarction, cerebrovascular accident and intracranial haemorrhage.
†A patient with cerebral haemorrhage and a patient with intracranial haemorrhage were reported twice in this table (reported under stroke and non-ocular haemorrhage).
‡Includes amaurosis and carotid artery stenosis.
The incidence rates for events of special interest were derived by summating the incidence rates of the relevant preferred terms. With this approach, patients might be counted more than once, which could have led to a conservative overestimation of the rate.
HELIOS, Health Economics with Lucentis In Observational Settings; WAVE, Lucentis in Wet AMD: Evaluation of Visual Acuity and Quality of Life.