Two studies included an intervention arm only and 1 study included a control arm only (none of the patients received idarucizumab).109 We combined the number of events and the total number of patients from the 3 studies to calculate a relative effect. All studies included patients receiving dabigatran presenting with life-threatening bleeding; 1 included some patients who were not bleeding but required urgent dabigatran reversal for invasive procedures. All studies reported the outcomes of life-threatening bleeding associ- ated with dabigatran therapy, including death, worsening and/or recurrence of bleeding, and thromboembolic complications. The EtD framework is shown online at https://dbep.gradepro.org/ profile/b1deb68f-2ed2-4734-bb86-0a66117969cd. Benefits. For benefits, see the evidence profile in the EtD framework referenced at the end of the previous section, available online. Idarucizumab administration may or may not reduce the mortality risk (RR, 0.47 [95% CI, 0.14-1.58]; ARR, 151 fewer deaths per 1000 [95% CI, 246 fewer to 166 more per 1000]; very low certainty) and worsening and/or recurrence of bleeding associated with life-threatening bleeding during dabigatran therapy (RR, 0.12 [95% CI, 0.03-0.43]; ARR, 251 fewer bleeding episodes per 1000 [95% CI, 163 fewer to 277 fewer per 1000]; very low certainty); the CIs are very wide and include large risk reductions and increases. Harms and burden. There were 5 VTE events (3 DVTs and 2 PEs) reported following idarucizumab administration in 1 study.195 Estimating the relative and absolute risk estimates was not possible, as there were no VTEs in the comparison group. The certainty in these estimated effects is very low. Other EtD criteria and considerations. The acquisition cost of idarucizumab is considerable, although no formal economic analyses are available. Conclusions and research needs for this recommendation. 