Table 4.

Deaths reported by study phase.

	Consolidation phase N = 215	TFR phase N = 190	Re-initiation phase N = 91	Post treatment follow-up	All
Primary cause of death - preferred term	n (%)	n (%)	n (%)	n	n
Total	2 (0.9)	1 (0.5)	4 (4.4)	3	10
Unknown cause	0	1 (0.5)	1 (1.1)	1a,b	3
Other cancers	0	0	0	2a	2
Acute myocardial infarction	0	0	1 (1.1)	0	1
Cardiac arrest	1 (0.5)	0	0	0	1
Suicide	1 (0.5)	0	0	0	1
Hepatobiliary cancer	0	0	1 (1.1)b	0	1
Respiratory failure	0	0	1 (1.1)	0	1

TFR, treatment-free remission.

^aDeaths were reported >30 days after patients discontinued the study.

^bNew deaths reported since the 96-week data cut-off date.