Baseline characteristics and 6-month study outcomes of included randomized trials
| Study name . | Year . | Treatment allocation* . | Baseline characteristics . | Study outcomes . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Male . | Age (mean/median with SD/IQR), y . | Index event PE ± DVT . | Incidental VTE . | Prior VTE . | Metastatic disease¶ . | Gastro-intestinal cancer . | Recurrent VTE† . | Major bleeding . | Clinically relevant nonmajor bleeding . | All-cause mortality . | |||
| Hokusai VTE Cancer | 2018 | Edoxaban, n = 522‡ | 277 (53.1) | 64 ± 11 | 328 (62.8) | 167 (32.0) | 49 (9.4) | 274 (52.5) | 165 (31.6) | 34 (6.5) | 29 (5.6) | 64 (12.3) | 140 (26.8) |
| Dalteparin, n = 524 | 263 (50.2) | 63 ± 12 | 329 (62.8) | 173 (33.0) | 63 (12.0) | 280 (53.4) | 140 (26.7) | 46 (8.8) | 17 (3.2) | 43 (8.2) | 127 (24.2) | ||
| Select-D | 2018 | Rivaroxaban, n = 203 | 116 (57.1) | 67 (22-87) | 150 (73.9) | 108 (53.2) | NR | 118 (58.1) | 94 (46.3) | 7 (3.4) | 11 (5.4) | 25 (12.3) | 48 (23.6) |
| Dalteparin, n = 203 | 98 (48.3) | 67 (34-87) | 145 (71.4) | 105 (51.7) | NR | 118 (58.1) | 86 (42.4) | 17 (8.4) | 6 (3.0) | 7 (3.5) | 56 (27.6) | ||
| ADAM-VTE§ | 2020 | Apixaban, n = 150 | 72 (48.0) | 64 ± 11 | 81 (54.0) | NR | 8 (5.3) | 96 (64.0) | 48 (32.0) | 0 (0) | 0 (0) | 9 (6.2) | 23 (15.9) |
| Dalteparin, n = 150 | 73 (48.7) | 64 ± 11 | 75 (50.0) | NR | 12 (8.0) | 97 (64.7) | 57 (38.0) | 5 (3.5) | 2 (1.4) | 7 (4.9) | 15 (10.6) | ||
| CARAVAGGIO | 2020 | Apixaban, n = 576 | 292 (50.7) | 67 ± 11 | 304 (52.8) | 116 (20.1) | 45 (7.8) | 389 (67.5) | 188 (32.6) | 32 (5.6) | 22 (3.8) | 52 (9.0) | 135 (23.4) |
| Dalteparin, n = 579 | 276 (47.7) | 67 ± 11 | 334 (57.7) | 114 (19.7) | 61 (10.5) | 396 (68.4) | 187 (32.3) | 46 (7.9) | 23 (4.0) | 35 (6.0) | 153 (26.4) | ||
| Study name . | Year . | Treatment allocation* . | Baseline characteristics . | Study outcomes . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Male . | Age (mean/median with SD/IQR), y . | Index event PE ± DVT . | Incidental VTE . | Prior VTE . | Metastatic disease¶ . | Gastro-intestinal cancer . | Recurrent VTE† . | Major bleeding . | Clinically relevant nonmajor bleeding . | All-cause mortality . | |||
| Hokusai VTE Cancer | 2018 | Edoxaban, n = 522‡ | 277 (53.1) | 64 ± 11 | 328 (62.8) | 167 (32.0) | 49 (9.4) | 274 (52.5) | 165 (31.6) | 34 (6.5) | 29 (5.6) | 64 (12.3) | 140 (26.8) |
| Dalteparin, n = 524 | 263 (50.2) | 63 ± 12 | 329 (62.8) | 173 (33.0) | 63 (12.0) | 280 (53.4) | 140 (26.7) | 46 (8.8) | 17 (3.2) | 43 (8.2) | 127 (24.2) | ||
| Select-D | 2018 | Rivaroxaban, n = 203 | 116 (57.1) | 67 (22-87) | 150 (73.9) | 108 (53.2) | NR | 118 (58.1) | 94 (46.3) | 7 (3.4) | 11 (5.4) | 25 (12.3) | 48 (23.6) |
| Dalteparin, n = 203 | 98 (48.3) | 67 (34-87) | 145 (71.4) | 105 (51.7) | NR | 118 (58.1) | 86 (42.4) | 17 (8.4) | 6 (3.0) | 7 (3.5) | 56 (27.6) | ||
| ADAM-VTE§ | 2020 | Apixaban, n = 150 | 72 (48.0) | 64 ± 11 | 81 (54.0) | NR | 8 (5.3) | 96 (64.0) | 48 (32.0) | 0 (0) | 0 (0) | 9 (6.2) | 23 (15.9) |
| Dalteparin, n = 150 | 73 (48.7) | 64 ± 11 | 75 (50.0) | NR | 12 (8.0) | 97 (64.7) | 57 (38.0) | 5 (3.5) | 2 (1.4) | 7 (4.9) | 15 (10.6) | ||
| CARAVAGGIO | 2020 | Apixaban, n = 576 | 292 (50.7) | 67 ± 11 | 304 (52.8) | 116 (20.1) | 45 (7.8) | 389 (67.5) | 188 (32.6) | 32 (5.6) | 22 (3.8) | 52 (9.0) | 135 (23.4) |
| Dalteparin, n = 579 | 276 (47.7) | 67 ± 11 | 334 (57.7) | 114 (19.7) | 61 (10.5) | 396 (68.4) | 187 (32.3) | 46 (7.9) | 23 (4.0) | 35 (6.0) | 153 (26.4) | ||
Data are expressed as No. (%) unless otherwise indicated. IQR, interquartile range; NR, not reported; SD, standard deviation.
Number of patients in (modified) intention-to-treat analysis.
Excluding splanchnic vein thrombosis and cerebral thrombosis.
A total of 122 (23.4%) patients receiving edoxaban met the criteria for dose reduction to 30 mg edoxaban once daily.
In the ADAM-VTE trial, baseline characteristics were presented for all 300 randomized patients, and the analysis was performed in the modified intention-to-treat population (n = 145 in the rivaroxaban group, n = 142 in the dalteparin group).
For the CARAVAGGIO study, this number also includes patients with recurrent locally advanced cancer.