Table 1.
Adverse events of special interest for bevacizumab or erlotinib
| MedDRA® preferred terms | All grades | Grade ≥3 | ||
|---|---|---|---|---|
| EB patients (n = 75) | E patients (n = 77) | EB patients (n = 75) | E patients (n = 77) | |
| Adverse events of special interest | ||||
| Rash | 74 (98.7) | 77 (100) | 18 (24.0) | 15 (19.5) |
| Diarrhea | 61 (81.3) | 61 (79.2) | 2 (2.7) | 1 (1.3) |
| Hypertensiona | 59 (78.7) | 11 (14.3) | 46 (61.3) | 9 (11.7) |
| Hypertension | 58 (77.3) | 11 (14.3) | 45 (60.0) | 9 (11.7) |
| Blood pressure increased | 1 (1.3) | 0 (0) | 1 (1.3) | 0 (0) |
| Non-pulmonary bleeding/hemorrhageb | 54 (72.0) | 22 (28.6) | 2 (2.7) | 0 (0) |
| Proteinuria | 41 (54.7) | 3 (3.9) | 6 (8.0) | 0 (0) |
| Pulmonary hemorrhage/hemoptysisb | 7 (9.3) | 1 (1.3) | 0 (0) | 0 (0) |
| Peripheral sensory neuropathy | 6 (8.0) | 3 (3.9) | 0 (0) | 0 (0) |
| Interstitial lung disease | 2 (2.7) | 3 (3.9) | 0 (0) | 1 (1.3) |
| Arterial thromboembolism | 2 (2.7) | 1 (1.3) | 2 (2.7) | 1 (1.3) |
| Venous thromboembolism | 1 (1.3) | 2 (2.6) | 1 (1.3) | 2 (2.6) |
| Anaphylaxis and hypersensitivity | 1 (1.3) | 1 (1.3) | 0 (0) | 0 (0) |
| Congestive heart failure | 1 (1.3) | 0 (0) | 0 (0) | 0 (0) |
| Wound healing disorders | 1 (1.3) | 0 (0) | 0 (0) | 0 (0) |
| Cardiovascular disorders | 0 (0) | 2 (2.6) | 0 (0) | 1 (1.3) |
| Neutropenia | 0 (0) | 2 (2.6) | 0 (0) | 1 (1.3) |
| Encephalopathy syndrome | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| GI perforation | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Data are presented as n (%) and are based on groups of preferred terms for AESIs
AESIs adverse events of special interest, E erlotinib alone, EB erlotinib plus bevacizumab, GI gastrointestinal, MedDRA Medical Dictionary for Regulatory Activities
aIncluding hypertension and increased blood pressure
bPatients could have both pulmonary and non-pulmonary bleeding; overall bleeding events occurred in 56 patients (74.7%) in the EB arm and 23 patients (29.9%) in the E arm