Characteristics at study inclusion of all patients, stratified according to the occurrence of a first bleeding event in the follow-up period
| . | Total study population (n = 791) . | Patients who developed CRB (n = 139) . | Patients who developed MB (n = 70) . | Patients who developed CRNMB (n = 87) . | Patients without bleeding (n = 652) . |
|---|---|---|---|---|---|
| Female | 377 (47.7) | 73 (52.5) | 27 (38.6) | 46 (52.9) | 312 (47.9) |
| Age, y | 63 (54-70) | 63 (55-70) | 64 (56-70) | 62 (53-70) | 63 (54-70) |
| BMI | 23.8 (20.8-26.9) | 23.3 (21.0-25.8) | 23.3 (21.1-26.0) | 22.9 (20.5-25.3) | 24.0 (20.8-27.1) |
| Tumor type | |||||
| Lung | 187 (23.6) | 34 (24.5) | 11 (15.7) | 25 (28.7) | 153 (23.5) |
| Head and neck | 88 (11.1) | 25 (18.0) | 14 (20.0) | 15 (17.2) | 63 (9.7) |
| Urinary | 15 (1.9) | 2 (1.4) | 0 | 2 (2.3) | 13 (2.0) |
| Breast | 74 (9.4) | 10 (7.2) | 4 (5.7) | 7 (8.0) | 64 (9.8) |
| Colorectal | 58 (7.3) | 7 (5.0) | 4 (5.7) | 3 (3.4) | 51 (7.8) |
| Pancreas | 82 (10.4) | 21 (15.1) | 17 (24.3) | 8 (9.2) | 61 (9.4) |
| Esophageal | 27 (3.4) | 6 (4.3) | 4 (5.7) | 3 (3.4) | 21 (3.2) |
| Stomach | 35 (4.4) | 8 (5.8) | 3 (4.3) | 7 (8.0) | 27 (4.1) |
| Brain | 52 (6.6) | 1 (0.7) | 1 (1.4) | 0 | 51 (7.8) |
| Liver | 38 (4.8) | 8 (5.8) | 4 (5.7) | 6 (6.9) | 30 (4.6) |
| Prostate | 6 (0.8) | 0 | 0 | 0 | 6 (0.9) |
| Sarcoma | 59 (7.5) | 5 (3.6) | 1 (1.4) | 4 (4.6) | 54 (8.3) |
| Lymphoma | 11 (1.4) | 0 | 0 | 0 | 11 (1.7) |
| Gynecological | 2 (0.3) | 1 (50.0) | 0 | 1 (1.1) | 1 (0.2) |
| Other | 57 (7.2) | 12 (8.6) | 7 (10) | 6 (6.9) | 45 (6.9) |
| Newly diagnosed cancer | 403 (51.0) | 72 (51.8) | 34 (48.6) | 47 (54.0) | 331 (50.8) |
| Recurrent or progressive cancer | 388 (49.0) | 68 (48.2) | 36 (51.4) | 40 (46.0) | 320 (49.2) |
| Stage of cancer | |||||
| Localized | 84 (10.6) | 12 (8.6) | 6 (8.6) | 7 (8.0) | 72 (11.1) |
| Lymph nodes | 136 (17.2) | 36 (25.9) | 16 (22.9) | 25 (28.7) | 100 (15.4) |
| Distant metastatic | 518 (65.5) | 90 (64.7) | 46 (65.7) | 55 (63.2) | 428 (65.7) |
| Systemic therapy after study inclusion | |||||
| Chemotherapy | 361 (45.6) | 64 (46.0) | 35 (50.0) | 34 (39.1) | 297 (45.6) |
| Immune checkpoint inhibitor therapy | 136 (17.2) | 26 (18.7) | 10 (14.3) | 20 (23.0) | 110 (16.9) |
| Chemotherapy and immune checkpoint inhibitor therapy | 128 (16.2) | 31 (22.3) | 12 (17.1) | 22 (25.3) | 97 (14.9) |
| Targeted therapy and chemotherapy | 90 (11.4) | 13 (9.4) | 8 (11.4) | 9 (10.3) | 77 (11.8) |
| Targeted | 38 (4.8) | 1 (0.7) | 1 (1.4) | 0 | 37 (5.7) |
| No systemic therapy | 27 (3.3) | 1 (0.7) | 1 (1.4) | 0 | 26 (4.0) |
| Targeted and immune checkpoint inhibitor therapy | 10 (1.3) | 4 (2.9) | 3 (4.3) | 2 (2.3) | 6 (0.9) |
| Tyrosine kinase inhibitors | 1 (0.1) | 0 | 0 | 0 | 1 (0.2) |
| History of any bleeding | 117 (14.8) | 21 (15.1) | 7 (10.0) | 15 (17.2) | 96 (14.7) |
| History of VTE | 98 (12.4) | 14 (10.1) | 7 (10.0) | 8 (9.2) | 84 (12.9) |
| History of ATE | 70 (8.8) | 12 (8.6) | 4 (5.7) | 8 (9.2) | 58 (8.9) |
| Arterial hypertension | 279 (35.3) | 57 (41.0) | 23 (32.9) | 38 (43.7) | 222 (34.0) |
| Atrial fibrillation | 49 (6.2) | 15 (10.8) | 8 (11.4) | 9 (10.3) | 34 (5.2) |
| Therapeutic anticoagulation∗ | 120 (15.2) | 23 (16.5) | 13 (18.6) | 12 (13.8) | 97 (14.9) |
| Antiplatelet therapy | 124 (15.7) | 26 (18.7) | 12 (17.1) | 18 (20.7) | 98 (15.0) |
| ECOG PS score | |||||
| 0 | 497 (62.8) | 83 (59.7) | 36 (51.4) | 53 (60.9) | 414 (63.6) |
| 1 | 206 (26.0) | 42 (30.2) | 22 (31.4) | 28 (32.2) | 164 (25.5) |
| 2 | 48 (6.1) | 11 (7.9) | 10 (14.3) | 3 (3.4) | 37 (5.7) |
| 3 | 3 (0.4) | 0 | 0 | 0 | 3 (0.5) |
| . | Total study population (n = 791) . | Patients who developed CRB (n = 139) . | Patients who developed MB (n = 70) . | Patients who developed CRNMB (n = 87) . | Patients without bleeding (n = 652) . |
|---|---|---|---|---|---|
| Female | 377 (47.7) | 73 (52.5) | 27 (38.6) | 46 (52.9) | 312 (47.9) |
| Age, y | 63 (54-70) | 63 (55-70) | 64 (56-70) | 62 (53-70) | 63 (54-70) |
| BMI | 23.8 (20.8-26.9) | 23.3 (21.0-25.8) | 23.3 (21.1-26.0) | 22.9 (20.5-25.3) | 24.0 (20.8-27.1) |
| Tumor type | |||||
| Lung | 187 (23.6) | 34 (24.5) | 11 (15.7) | 25 (28.7) | 153 (23.5) |
| Head and neck | 88 (11.1) | 25 (18.0) | 14 (20.0) | 15 (17.2) | 63 (9.7) |
| Urinary | 15 (1.9) | 2 (1.4) | 0 | 2 (2.3) | 13 (2.0) |
| Breast | 74 (9.4) | 10 (7.2) | 4 (5.7) | 7 (8.0) | 64 (9.8) |
| Colorectal | 58 (7.3) | 7 (5.0) | 4 (5.7) | 3 (3.4) | 51 (7.8) |
| Pancreas | 82 (10.4) | 21 (15.1) | 17 (24.3) | 8 (9.2) | 61 (9.4) |
| Esophageal | 27 (3.4) | 6 (4.3) | 4 (5.7) | 3 (3.4) | 21 (3.2) |
| Stomach | 35 (4.4) | 8 (5.8) | 3 (4.3) | 7 (8.0) | 27 (4.1) |
| Brain | 52 (6.6) | 1 (0.7) | 1 (1.4) | 0 | 51 (7.8) |
| Liver | 38 (4.8) | 8 (5.8) | 4 (5.7) | 6 (6.9) | 30 (4.6) |
| Prostate | 6 (0.8) | 0 | 0 | 0 | 6 (0.9) |
| Sarcoma | 59 (7.5) | 5 (3.6) | 1 (1.4) | 4 (4.6) | 54 (8.3) |
| Lymphoma | 11 (1.4) | 0 | 0 | 0 | 11 (1.7) |
| Gynecological | 2 (0.3) | 1 (50.0) | 0 | 1 (1.1) | 1 (0.2) |
| Other | 57 (7.2) | 12 (8.6) | 7 (10) | 6 (6.9) | 45 (6.9) |
| Newly diagnosed cancer | 403 (51.0) | 72 (51.8) | 34 (48.6) | 47 (54.0) | 331 (50.8) |
| Recurrent or progressive cancer | 388 (49.0) | 68 (48.2) | 36 (51.4) | 40 (46.0) | 320 (49.2) |
| Stage of cancer | |||||
| Localized | 84 (10.6) | 12 (8.6) | 6 (8.6) | 7 (8.0) | 72 (11.1) |
| Lymph nodes | 136 (17.2) | 36 (25.9) | 16 (22.9) | 25 (28.7) | 100 (15.4) |
| Distant metastatic | 518 (65.5) | 90 (64.7) | 46 (65.7) | 55 (63.2) | 428 (65.7) |
| Systemic therapy after study inclusion | |||||
| Chemotherapy | 361 (45.6) | 64 (46.0) | 35 (50.0) | 34 (39.1) | 297 (45.6) |
| Immune checkpoint inhibitor therapy | 136 (17.2) | 26 (18.7) | 10 (14.3) | 20 (23.0) | 110 (16.9) |
| Chemotherapy and immune checkpoint inhibitor therapy | 128 (16.2) | 31 (22.3) | 12 (17.1) | 22 (25.3) | 97 (14.9) |
| Targeted therapy and chemotherapy | 90 (11.4) | 13 (9.4) | 8 (11.4) | 9 (10.3) | 77 (11.8) |
| Targeted | 38 (4.8) | 1 (0.7) | 1 (1.4) | 0 | 37 (5.7) |
| No systemic therapy | 27 (3.3) | 1 (0.7) | 1 (1.4) | 0 | 26 (4.0) |
| Targeted and immune checkpoint inhibitor therapy | 10 (1.3) | 4 (2.9) | 3 (4.3) | 2 (2.3) | 6 (0.9) |
| Tyrosine kinase inhibitors | 1 (0.1) | 0 | 0 | 0 | 1 (0.2) |
| History of any bleeding | 117 (14.8) | 21 (15.1) | 7 (10.0) | 15 (17.2) | 96 (14.7) |
| History of VTE | 98 (12.4) | 14 (10.1) | 7 (10.0) | 8 (9.2) | 84 (12.9) |
| History of ATE | 70 (8.8) | 12 (8.6) | 4 (5.7) | 8 (9.2) | 58 (8.9) |
| Arterial hypertension | 279 (35.3) | 57 (41.0) | 23 (32.9) | 38 (43.7) | 222 (34.0) |
| Atrial fibrillation | 49 (6.2) | 15 (10.8) | 8 (11.4) | 9 (10.3) | 34 (5.2) |
| Therapeutic anticoagulation∗ | 120 (15.2) | 23 (16.5) | 13 (18.6) | 12 (13.8) | 97 (14.9) |
| Antiplatelet therapy | 124 (15.7) | 26 (18.7) | 12 (17.1) | 18 (20.7) | 98 (15.0) |
| ECOG PS score | |||||
| 0 | 497 (62.8) | 83 (59.7) | 36 (51.4) | 53 (60.9) | 414 (63.6) |
| 1 | 206 (26.0) | 42 (30.2) | 22 (31.4) | 28 (32.2) | 164 (25.5) |
| 2 | 48 (6.1) | 11 (7.9) | 10 (14.3) | 3 (3.4) | 37 (5.7) |
| 3 | 3 (0.4) | 0 | 0 | 0 | 3 (0.5) |
Values are presented as absolute numbers (percentages) or median (IQR). Percentages are calculated per column.
ATE, arterial thromboembolism; BMI, body mass index; ECOG PS, Eastern Cooperative Oncology Group performance status.
Defined as anticoagulation for VTE treatment or anticoagulation for stroke prevention in atrial fibrillation or anticoagulation in patients with mechanical heart valves or vascular grafts.