Table 2. . Adverse events of interest reported in GOG-0218, ICON 7, OCEANS, GOG-0213, and AURELIA.
| Adverse event† | GOG-0218‡ | ICON7 | OCEANS | GOG-0213 | AURELIA | Relative risk (95% CI)§ |
|---|---|---|---|---|---|---|
| Hypertension, (grade ≥2) | 22.9% | 18% | 18.2% (grade ≥3) | 32% | 20% | 4.09 (3.84–6.25) |
| Proteinuria, (grade ≥3) | 1.6% | 1% | 10.9% | 8% | 10.6% | 6.63 (3.17–13.88) |
| GI events, (grade ≥2, perforation, fistula, necrosis, anastamotic leak) | 2.6% | 1% | 2.4% | 2% | 4.4% | Perforation 2.90 (1.45–5.82) Fistula or abscess 1.70 (0.7–3.97) |
| Thromboembolic events, (all grades) | 7.4% (6.7% VTE) | 11% | 6.9% (4.5% VTE) | 7% (all ATE) | 5% | ATE 2.29 (1.33–3.75) VTE 1.32 (0.995–1.82) |
| Non-CNS bleeding, (grade ≥3) | 2.1% | 1% | 6.5% | 1.8% | 1.1% | 3.63 (1.81–7.29) |
| CNS bleeding, (all grades) | 0.3% | <1% | 0.8% | 0.3% | Not reported | 3.42 (0.72–16.35) |
| PRES | 0.2% | 0 | 0.8% | 0 | 0.6% | 4.23 (0.72–25.03) |
| Impaired wound healing, (all grades) | 3.6% | 5% | 0.8% | 3% | 0 | 1.48 (0.85–2.57) |
†
Patients randomized to bevacizumab arm.
‡
Bev-throughout group (Arm 3).
§
Bevacizumab containing arm compared with chemotherapy alone. Excludes GOG-0213 as results not available at time of analysis.
ATE: Arterial thromboembolism; CNS: Central nervous system; GI: Gastrointestinal; PRES: Posterior reversible encephalopathy syndrome; VTE: Venous thromboembolism.