TABLE 3.
Clinical characteristics of pulmonary haemorrhage and haemoptysis cases reported for BV-related regimens from the FAERS database.
| Characteristics | Overall (n = 497) | BV monotherapy (n = 150) | BV plus chemotherapy (n = 292) | BV plus ICI (n = 13) | BV plus targeted therapy (n = 42) |
|---|---|---|---|---|---|
| Gender | |||||
| Female | 172 (34.6%) | 42 (28.0%) | 111 (38.0%) | 3 (23.1%) | 16 (38.1%) |
| Male | 213 (42.9%) | 66 (44.0%) | 121 (41.4%) | 9 (69.2%) | 17 (40.5%) |
| Unknown | 112 (22.5%) | 42 (28.0%) | 60 (20.5%) | 1 (7.7%) | 9 (21.4%) |
| Reporting year | |||||
| 2019–2023 | 91 (18.3%) | 27 (18.0%) | 47 (16.1%) | 13 (100.0%) | 4 (9.5%) |
| 2014–2018 | 178 (35.8%) | 67 (44.7%) | 91 (31.2%) | 0 (0.0%) | 20 (47.6%) |
| 2009–2013 | 143 (28.8%) | 31 (20.7%) | 105 (36.0%) | 0 (0.0%) | 7 (16.7%) |
| 2008 and before | 85 (17.1%) | 25 (16.7%) | 49 (16.8%) | 0 (0.0%) | 11 (26.2%) |
| Indications | |||||
| Lung cancer | 264 (53.1%) | 60 (40.0%) | 176 (60.3%) | 10 (76.9%) | 18 (42.9%) |
| Colorectal cancer | 61 (12.3%) | 21 (14.0%) | 39 (13.4%) | 0 (0.0%) | 1 (2.4%) |
| Breast cancer | 35 (7.0%) | 7 (4.7%) | 24 (8.2%) | 0 (0.0%) | 4 (9.5%) |
| Renal cancer | 19 (3.8%) | 14 (9.3%) | 3 (1.0%) | 0 (0.0%) | 2 (4.8%) |
| Gastric cancer | 9 (1.8%) | 0 (0.0%) | 4 (1.4%) | 0 (0.0%) | 5 (11.9%) |
| Head and neck cancer | 8 (1.6%) | 2 (1.3%) | 5 (1.7%) | 0 (0.0%) | 1 (2.4%) |
| Ovarian cancer | 7 (1.4%) | 2 (1.3%) | 4 (1.4%) | 0 (0.0%) | 1 (2.4%) |
| Uterus cancer | 7 (1.4%) | 1 (0.7%) | 6 (2.1%) | 0 (0.0%) | 0 (0.0%) |
| Liver cancer | 6 (1.2%) | 2 (1.3%) | 1 (0.3%) | 3 (23.1%) | 0 (0.0%) |
| Others | 27 (5.4%) | 12 (8.0%) | 9 (3.1%) | 0 (0.0%) | 6 (14.3%) |
| Unspecified | 54 (10.9%) | 29 (19.3%) | 21 (7.2%) | 0 (0.0%) | 4 (9.5%) |
| Serious outcomes | |||||
| Death (DE) | 226 (45.5%) | 57 (38.0%) | 148 (50.7%) | 6 (46.2%) | 15 (35.7%) |
| Life-threatening (LT) | 8 (1.6%) | 1 (0.7%) | 6 (2.1%) | 1 (7.7%) | 0 (0.0%) |
| Hospitalization–initial or prolonged (HO) | 96 (19.3%) | 25 (16.7%) | 53 (18.2%) | 3 (23.1%) | 15 (35.7%) |
| Disability (DS) | 3 (0.6%) | 0 (0.0%) | 3 (1.0%) | 0 (0.0%) | 0 (0.0%) |
| Other serious (important medical event) (OT) | 121 (24.3%) | 48 (32.0%) | 59 (20.2%) | 2 (15.4%) | 12 (28.6%) |
| Unspecified | 43 (8.7%) | 19 (12.7%) | 23 (7.9%) | 1 (7.7%) | 0 (0.0%) |
| Reported countries | |||||
| United states | 241 (48.5%) | 96 (64.0%) | 114 (39.0%) | 3 (23.1%) | 28 (66.7%) |
| Japan | 71 (14.3%) | 8 (5.3%) | 56 (19.2%) | 5 (38.5%) | 2 (4.8%) |
| China | 32 (6.4%) | 12 (8.0%) | 17 (5.8%) | 0 (0.0%) | 3 (7.1%) |
| United Kingdom | 27 (5.4%) | 5 (3.3%) | 18 (6.2%) | 1 (7.7%) | 3 (7.1%) |
| Germany | 30 (6.0%) | 8 (5.3%) | 19 (6.5%) | 0 (0.0%) | 3 (7.1%) |
| Others | 79 (15.9%) | 17 (11.3%) | 55 (18.8%) | 4 (30.8%) | 3 (7.1%) |
| Unspecified | 17 (3.4%) | 4 (2.7%) | 13 (4.5%) | 0 (0.0%) | 0 (0.0%) |
| Reporters | |||||
| Physicians (MD) | 291 (58.6%) | 77 (51.3%) | 178 (61.0%) | 10 (76.9%) | 26 (61.9%) |
| Pharmacist (PH) | 27 (5.4%) | 15 (10.0%) | 10 (3.4%) | 0 (0.0%) | 2 (4.8%) |
| Consumer (CN) | 46 (9.3%) | 25 (16.7%) | 19 (6.5%) | 1 (7.7%) | 1 (2.4%) |
| health professional (HP) | 25 (5.0%) | 3 (2.0%) | 18 (6.2%) | 2 (15.4%) | 2 (4.8%) |
| Other health professional (OT) | 98 (18.7%) | 25 (16.7%) | 58 (19.9%) | 0 (0.0%) | 10 (23.8%) |
| Unspecified | 15 (3.0%) | 5 (3.3%) | 9 (3.1%) | 0 (0.0%) | 1 (2.4%) |