Table 2.
VTE incidence
| Overall (N=2299) |
ICI (N=605) |
Chemo (N=1092) |
ICI+chemo (N=602) |
|
| Cumulative incidence | ||||
| Median time to event (IQR), months | 3.4 (1.4–9.2) | 3.3 (1.3–8.9) | 3.9 (1.5–10.3) | 2.9 (1.2–7.4) |
| Overall VTE cumulative incidence during 6-month follow-up period (95% CI), cases per 100 patients | 10.7 (9.3 to 12.0) | 8.1 (5.8 to 10.4) | 10.9 (8.9 to 12.9) | 12.8 (11.3 to 14.3) |
| PE | 6.6 (5.6 to 7.7) | 5.1 (3.3 to 6.9) | 6.5 (5.0 to 8.0) | 8.3 (7.1 to 9.5) |
| DVT, lower extremity | 4.9 (4.0 to 5.8) | 4.5 (2.8 to 6.2) | 5.0 (3.7 to 6.4) | 5.0 (4.1 to 5.9) |
| DVT, upper extremity | 1.7 (1.2 to 2.2) | 1.5 (NA) | 1.7 (0.9 to 2.4) | 2.0 (1.4 to 2.6) |
| Other | 0.8 (0.5 to 1.2) | 0.5 (NA) | 1.0 (0.4 to 1.6) | 0.8 (NA) |
| Overall VTE cumulative incidence during 12-month follow-up period (95% CI), cases per 100 patients | 13.9 (12.4 to 15.4) | 11.6 (8.9 to 14.3) | 14.0 (11.8 to 16.2) | 16.1 (14.5 to 17.8) |
| PE | 8.7 (7.5 to 9.9) | 7.1 (5.0 to 9.2) | 8.6 (6.9 to 10.4) | 10.3 (9.0 to 11.6) |
| DVT, lower extremity | 6.4 (5.3 to 7.4) | 6.1 (4.2 to 8.1) | 6.4 (4.9 to 7.9) | 6.5 (5.4 to 7.5) |
| DVT, upper extremity | 2.2 (1.6 to 2.8) | 2.0 (0.9 to 3.1) | 2.1 (1.3 to 3.0) | 2.5 (1.9 to 3.1) |
| Other | 1.1 (0.7 to 1.6) | 0.7 (NA) | 1.3 (0.6 to 2.0) | 1.3 (NA) |
| Overall VTE cumulative incidence during complete follow-up period (95% CI), cases per 100 patients | 16.8 (15.2 to 18.5) | 13.4 (10.5 to 16.3) | 18.0 (15.5 to 20.6) | 18.1 (16.4 to 19.8) |
| PE | 10.6 (9.3 to 12.0) | 8.8 (6.4 to 11.1) | 11.0 (9.0 to 13.0) | 11.8 (10.4 to 13.2) |
| DVT, lower extremity | 7.6 (6.5 to 8.7) | 6.9 (4.8 to 9.0) | 8.0 (6.3 to 9.6) | 7.6 (6.5 to 8.8) |
| DVT, upper extremity | 2.8 (2.1 to 3.5) | 2.0 (0.9 to 3.1) | 3.3 (2.2 to 4.4) | 2.8 (2.1 to 3.5) |
| Other | 1.5 (1.0 to 2.0) | 0.7 (NA) | 1.7 (1.0 to 2.5) | 1.8 (1.3 to 2.4) |
| Incidence rates | ||||
| Overall VTE incidence rate during entire follow-up period (95% CI), cases per 100 PY | 17.8 (16.0 to 19.5) | 13.5 (10.6 to 16.5) | 18.0 (15.5 to 20.5) | 22.4 (20.2 to 24.5) |
| PE | 10.7 (9.4 to 12.1) | 8.6 (6.3 to 10.9) | 10.4 (8.6 to 12.3) | 14.0 (12.4 to 15.7) |
| DVT, lower extremity | 7.6 (6.4 to 8.7) | 6.7 (4.7 to 8.8) | 7.4 (5.9 to 9.0) | 8.8 (7.5 to 10.1) |
| DVT, upper extremity | 2.8 (2.1 to 3.4) | 1.9 (0.8 to 2.9) | 3.0 (2.0 to 4.0) | 3.2 (2.4 to 4.0) |
| Other | 1.4 (0.9 to 1.9) | 0.6 (NA) | 1.6 (0.9 to 2.3) | 2.1 (1.4 to 2.7) |
| Overall VTE incidence rate or anticoagulant within 3 days of venous ultrasound (95% CI), cases per 100 PY | 18.7 (16.8 to 20.5) | 13.8 (10.8 to 16.8) | 19.0 (16.4 to 21.5) | 24.0 (21.8 to 26.3) |
| Overall VTE incidence rate (first event of PE, DVT, or other) by baseline use of oral anticoagulant (95% CI), cases per 100 PY | ||||
| Yes | 15.3 (9.6 to 20.9) | 16.2 (NA) | 11.7 (5.1 to 18.4) | 25.1 (NA) |
| No | 18.0 (16.1 to 19.8) | 13.3 (10.3 to 16.4) | 18.6 (16.0 to 21.3) | 22.2 (20.0 to 24.4) |
DVT, deep vein thrombosis; ICI, immune checkpoint inhibitor; NA, not available; PE, pulmonary embolism; PY, patient-years; VTE, venous thromboembolism.