Table 3.

Clinically significant (≥ Grade 2) treatment-emergent bleeding or clotting events

Across the platform (n = 204)	Total	No aPTT data during event	aPTT normal/Grade 1 during event	aPTT ≥ Grade 2 during event
Bleeding events	3	2	1	0
		EVOLVE: Grade 2 hemorrhoidal hemorrhage. aPTT: No data collected.	STAR: Grade 3 perihepatic hemorrhage (post-procedural). aPTT: Grade 1 (36.6 s) 1 day after event start
		SPICE: Grade 2 hematuria.a aPTT: Grade 1 (42.6 s) 5 days before event.
Thrombotic events	6	2	2	2
		SPICE: Grade 3 deep vein thrombosis.a aPTT: Grade 1 (42.6 s) 38 days before event	OCTAVE: Grade 3 thromboembolic pulmonary event. aPTT: Grade 1 (44.4 s) 13 days after event start	OCTAVE: Grade 2 embolism.b aPTT: • Grade 3 (120 s) 21 days after event start • Grade 3 (201.6 s) 25 days after event start • Grade 2 (69.1 s) 42 days after event start
		STAR: Grade 3 pulmonary embolism. aPTT Grade 2 (81.8 s) 28 days before event	SPICE: Grade 3 (SAE) pulmonary embolism. aPTT: • Grade 1 (42.9 s) 8 days after event start • Grade 2 (86.6 s) 22 days after event start • Grade 1 (39.2 s) 29 days after event start	SPICE: Grade 2 disseminated intravascular coagulation. aPTT: • Grade 2 (73.3 s) on event start • Grade 3 (95.7 s) 15 days after event start • Grade 2 (83.5 s) 23 days after event start • Grade 1 (44.7 s) 107 days after event start

aPTT = activated partial thromboplastin time; ISTH = International Society on Thrombosis and Haemostasis; SAE = serious adverse event

^aIn the SPICE study, hematuria and deep vein thrombosis occurred in the same patient

^baPTT was Grade 3 (132.9 s) one week before the event started (Day 3). Patient also experienced a Grade 2 hepatic hemorrhage prior to initiation of study treatment (aPTT normal at the time of event [28.9 s])