1. APEX: Primary Efficacy and Safety Results
Cohort 1
D-dimer ≥ 2 ULN
Cohort 2
D-dimer ≥ 2 ULN or Age ≥ 75
Overall
p = 0.054
RRR 19.4%
p = 0.029
RRR 20.0%
p = 0.006
RRR 24.0% 12
VTE Events
Major Bleeding
7.05%
7.03%
5.63%
5.30% 6
Incidence (%) 2
p = 0.72
p = 0.56
p = 0.55
Enoxaparin
Betrixaban
Enoxaparin
Betrixaban
Enoxaparin
Betrixaban
Median treatment duration:
9 days of enoxaparin
36 days of betrixaban
Cohen AT et al NEJM 2016;375(6):534-44

2. Symptomatic VTE 1.84% 1.44% p=0.004 Enoxaparin 1.04% 0.93% Betrixaban
Composite of Symptomatic Proximal or Distal DVT, Non-Fatal PE, or VTE-related Death
Probability of Symptomatic Event (%)
Time (Days)
Enoxaparin
Betrixaban
1.44%
0.93%
Through Visit 3
HR = (0.42, 0.99)
ARR = 0.51%
NNT = 196
p=0.043
Through End of Trial*
HR = (0.38, 0.84)
ARR = 0.80%
NNT = 125
p=0.004
1.84%
1.04%
Parenteral
Therapy
Visit 3
Cohen AT et al NEJM 2016;375(6):534-44
*End of Trial defined as final follow-up visit ( days after Visit 3) 2

3. During Standard prophylaxis period: Symptomatic Events

4. Extended betrixaban period to Day 6-35: Symptomatic Event

5. Follow-up period to End of Study (after 35-42 days):
Symptomatic Event

6. Major Bleeding: KM Estimates and Hazard Ratios
Betrixaban
Enoxaparin
Hazard Ratio (95% CI)
p-value
Standard prophylaxis period
Major Bleeding
9/3714 (1.37%)
9/3716 (2.86%)
1.07 ( )
0.88
Extended betrixaban period
16/3645 (0.53%)
12/3632 (0.33%)
1.33 ( )
0.45
Follow-up period
0/3488
0/3510 -

7. Kaplan‑Meier Plots for Adjudicated Major Bleeding Events
through Seven Days after Discontinuation of All Study Medication