Table 3.

Stroke and bleeding outcomes after AF onset

All AF (n = 76)Incident AF (n = 63)Recurrent AF (n = 13)
Stroke/TIA, n (%) 1 (1.3) 1 (7.7) 
Major bleeding events,*
Major bleed type, no. of events    
 Intracranial 
 Intraocular 
 Gastrointestinal 
 Surgical 
 Other 
Concomitant antiplatelet, n 
Concomitant anticoagulant, n 
Ibrutinib status after bleed, n    
 No change 
 Temporary hold 
 Discontinued 
CRNMB    
 CRNMB events, n 26 23 
CRNMB type, no. of events    
 Genitourinary 
 Pulmonary 
 Gastrointestinal 
 Dermatologic 
 Epistaxis 
 Oral 
 Surgical 
 Ecchymosis 
 Other 
Concomitant antiplatelet, n 12 
Concomitant anticoagulant, n 
Ibrutinib status after bleed, n    
 No change 16 14 
 Temporary hold 
 Discontinued 
All AF (n = 76)Incident AF (n = 63)Recurrent AF (n = 13)
Stroke/TIA, n (%) 1 (1.3) 1 (7.7) 
Major bleeding events,*
Major bleed type, no. of events    
 Intracranial 
 Intraocular 
 Gastrointestinal 
 Surgical 
 Other 
Concomitant antiplatelet, n 
Concomitant anticoagulant, n 
Ibrutinib status after bleed, n    
 No change 
 Temporary hold 
 Discontinued 
CRNMB    
 CRNMB events, n 26 23 
CRNMB type, no. of events    
 Genitourinary 
 Pulmonary 
 Gastrointestinal 
 Dermatologic 
 Epistaxis 
 Oral 
 Surgical 
 Ecchymosis 
 Other 
Concomitant antiplatelet, n 12 
Concomitant anticoagulant, n 
Ibrutinib status after bleed, n    
 No change 16 14 
 Temporary hold 
 Discontinued 
*

Major bleed is defined as fatal bleeding, symptomatic bleeding in a critical organ (eg, intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, intramuscular), or bleeding that resulted in a hemoglobin drop of at least 2 g/dL or required at least 2 units of blood; major bleeding is reported on an event level (patients could have multiple bleeding events).

CRNMB is defined as bleeding that did not meet the ISTH criteria for major bleed but met at least 1 of the following criteria: (1) required medical intervention, (2) hospitalization, or (3) face-to-face evaluation; CRNMB is reported on an event level (patients could have multiple bleeding events).

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