D-dimer status from the local laboratory. The analyses are not adjusted for multiplicity. ‡ Symptomatic events include symptomatic DVT, non-fatal PE or VTE-related death.
Composite Outcome 165 (4.4) 223 (6.0) 0.75 (0.61, 0.91)
Asymptomatic Event 133 (3.6) 176 (4.7)
Symptomatic DVT 14 (0.4) 22 (0.6)
Non-fatal PE 9 (0.2) 18 (0.5)
VTE-related Death 13 (0.3) 17 (0.5)
Symptomatic Events ‡ 35 (0.9) 54 (1.5) 0.64 (0.42, 0.98)
For patients with D-dimer ≥ 2 ULN at baseline, the event rate is 5.7% in the BEVYXXA arm vs. 7.2% in the enoxaparin arm (relative risk = 0.79, 95% CI [0.63, 0.98]).
For patients with D-dimer ≥ 2 ULN at baseline or age ≥ 75 years, the event rate is 4.7% in the BEVYXXA arm vs. 6.0% in the enoxaparin arm (relative risk = 0.78, 95% CI [0.64, 0.96]).
Results for the primary efficacy analysis for subjects that were stratified at randomization to the 80 mg BEVYXXA dose group in the mITT population are shown in Table 6 below.
Patients who were randomized to receive 40 mg BEVYXXA (those with severe renal impairment or receiving P-gp inhibitors), had VTE rates similar to the enoxaparin arm (6 to 14 days followed by placebo) shown in Table 7 below.
Table 6: Efficacy Outcomes in APEX Trial (mITT Population) – Patients Stratified to 80 mg BEVYXXA Dose
BEVYXXA
N=2,878
n (%) * Enoxaparin
N=2,926
n (%) * Relative Risk
(95% CI) †
* Percentages and event rates are based on the total number of patients and events included in each treatment group and stratified to 80 mg dose. † Relative Risk (BEVYXXA arm versus enoxaparin arm) is based on the Mantel-Haenszel test stratified by D-dimer status from the local laboratory. The analyses are not adjusted for multiplicity. ‡ Symptomatic events include symptomatic DVT, non-fatal PE, or VTE-related death.
Composite Outcome 120 (4.2) 180 (6.2) 0.68 (0.55, 0.86)
Asymptomatic Event 100 (3.5) 146 (5.0)
Symptomatic DVT 11 (0.4) 17 (0.6)
Non-fatal PE 4 (0.1) 14 (0.5)
VTE-related Death 8 (0.3) 12 (0.4)
Symptomatic Events ‡ 22 (0.8) 41 (1.4) 0.55 (0.33, 0.92)
Table 7: Efficacy Outcomes in APEX Trial (mITT Population) – Patients Stratified to 40 mg BEVYXXA Dose
Severe Renal Impairment Concomitant Use of P-gp Inhibitor
BEVYXXA
N=174
n (%) * Enoxaparin
N=149
n (%) * Relative Risk
(95% CI) † BEVYXXA
N=669
n (%) * Enoxaparin
N=645
n (%) * Relative Risk
(95% CI) †
* Percentages and event rates are based on the total number of patients and events included in each treatment group by dosing criteria. † Relative Risk (BEVYXXA arm versus enoxaparin arm) is based on the Mantel-Haenszel test stratified by D-dimer status from the local laboratory. The analyses are not adjusted for multiplicity. ‡ Symptomatic events include symptomatic DVT, non-fatal PE, or VTE-related death.
Composite Outcome 12 (6.9) 10 (6.7) 1.0
(0.45, 2.23) 33 (4.9) 33 (5.1) 1.0
(0.63, 1.60)
Asymptomatic Event 9 (5.2) 7 (4.7) 24 (3.6) 23 (3.6)
Symptomatic DVT 0 1 (0.7)&nbs |
