DETAILED OUTCOME DATA

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Edoxaban (Lixiana) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Apr.

Edoxaban (Lixiana) [Internet].

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APPENDIX 4DETAILED OUTCOME DATA

Table 16Results of Primary Outcome (Stroke or Systemic Embolic Event)

Primary End Point	Edoxaban 60 mg (N = 7,012)		Warfarin (N = 7,012)		Edoxaban 60 mg vs. Warfarin
First Stroke or SEE	No. of Events	Event Rate (%/year)	No. of Events	Event Rate (%/year)	HR (97.5% Cl)	P
mITT analysis set — on-treatment period	182	1.18	232	1.50	0.79 (0.632 to 0.985)	< 0.0001
mITT analysis set — overall study period	292	1.55	336	1.80	0.86 (0.719 to 1.029)	< 0.0001
	Edoxaban 60 mg (N = 6,995)		Warfarin (N = 6,993)		Edoxaban 60 mg vs. Warfarin
PP analysis set — on-treatment period	▬	▬	▬	▬	▬	▬
PP analysis set — overall study period	▬	▬	▬	▬	▬	▬
	Edoxaban 60 mg (N = 7,035)		Warfarin (N = 7,036)		Edoxaban 60 mg vs. Warfarin
ITT analysis set — overall study period	296	1.57	337	1.80	0.87 (0.709 to 1.068)	0.0807

: CI = confidence interval; HR = hazard ratio; ITT = intention-to-treat; mITT = modified intention-to-treat; PP = per-protocol; SEE = systemic embolic event.
: Source: CSR ENGAGE AF-TIMI 48;⁹ Giugliano, 2013.¹⁰

Table 17Results of Secondary Outcomes Through Different Analysis Sets

First Event	Edoxaban 60 mg (N = 7,035)		Warfarin (N = 7,036)		Edoxaban 60 mg vs. Warfarin
ITT Analysis Set — Overall Study Period	No. of Events	Event Rate (%/year)	No. of Events	Event Rate (%/year)	HR (95% CI)
Stroke, SEE, or CV mortality	728	3.85	831	4.43	0.87 (0.786 to 0.959)
MACE	827	4.41	926	4.98	0.89 (0.806 to 0.972)
Stroke, SEE, or all-cause mortality	949	5.01	1,046	5.57	0.90 (0.823 to 0.981)
First Event	Edoxaban 60 mg (N = 7,012)		Warfarin (N = 7,012)		Edoxaban 60 mg vs. Warfarin
mITT Analysis Set — On-Treatment Period	No. of Events	Event Rate (%/year)	No. of Events	Event Rate (%/year)	HR (95% Cl)
Stroke, SEE, or CV mortality	▬	▬	▬	▬	▬
MACE	▬	▬	▬	▬	▬
Stroke, SEE, or all-cause mortality	▬	▬	▬	▬	▬

: CI = confidence interval; CV = cardiovascular; HR = hazard ratio; ITT = intention-to-treat; MACE = major adverse cardiovascular event; mITT = modified intention-to-treat; SEE = systemic embolic event.
: Source: CSR ENGAGE AF-TIMI 48;⁹ Giugliano, 2013.¹⁰

Table 18Components of the Primary Outcome

First Event	Edoxaban 60 mg (N = 7,012)		Warfarin (N = 7,012)
ITT Analysis Set — Overall Study Period	No. of Events	Event Rate (%/year)	No. of Events	Event Rate (%/year)
Stroke	281	1.49	317	1.69
Ischemic stroke	236	1.25	235	1.25
Hemorrhagic stroke	49	0.26	90	0.47
Fatal stroke	80	0.42	86	0.45
Disabling stroke	54	0.28	57	0.30
SEE	15	0.08	23	0.12
SEE/ischemic stroke	251	1.33	255	1.36
mITT Analysis Set — On-Treatment Period
Stroke	174	1.13	219	1.41
Ischemic stroke	135	0.87	144	0.93
Hemorrhagic stroke	40	0.26	76	0.49
Fatal stroke	45	0.29	43	0.28
Disabling stroke	35	0.23	41	0.26
SEE	8	0.05	13	0.08
SEE/ischemic stroke	143	0.93	157	1.01

: ITT = intention-to-treat; mITT = modified intention-to-treat; SEE = systemic embolic event.
: Source: CSR ENGAGE AF-TIMI 48;⁹ Giugliano, 2013.¹⁰

Table 19Components of Secondary Outcomes

First Event	Edoxaban 60 mg (N = 7,035)		Warfarin (N = 7,036)
ITT Analysis Set — Overall Study Period	No. of Events	Event Rate (%/year)	No. of Events	Event Rate (%/year)
MI	133	0.70	141	0.75
Fatal	18	0.09	17	0.09
Non-fatal	117	0.62	125	0.66
CV mortality	530	2.74	611	3.17
All-cause mortality	773	3.99	839	4.35
mITT Analysis Set — On-Treatment Period
MI	88	0.57	105	0.68
Fatal	10	0.06	11	0.07
Non-fatal	78	0.50	94	0.60
CV mortality	208	1.34	236	1.51
All-cause mortality	234	1.51	258	1.65

: CV = cardiovascular; ITT = intention-to-treat; MI = myocardial infarction; mITT = modified intention-to-treat.
: Source: CSR ENGAGE AF-TIMI 48;⁹ Giugliano, 2013.¹⁰

Table 20Adjudicated Bleeding Events

	Edoxaban 60 mg (N = 7,012)		Warfarin (N = 7,012)
Bleeding Category — First Event	No. of Events	Event Rate (%/year)	No. of Events	Event Rate (%/year)
Major	418	2.75	524	3.43
ICH	61	0.39	132	0.85
N011-ICH	359	2.36	398	2.60
Fatal	32	0.21	59	0.38
ICH	24	0.15	42	0.27
N011-ICH	8	0.05	17	0.11
Non-fatal (major)	386	2.54	466	3.05
ICH	37	0.24	90	0.58
N011-ICH	351	2.31	381	2.49
Life-threatening	62	0.40	122	0.78
Clinically relevant non-major	1,214	8.67	1,396	10.15
Major or clinically relevant non-major	1,528	11.10	1,761	13.02
Minor	604	4.12	714	4.89
Any confirmed bleed	1,865	14.15	2,114	16.40

: ICH = intracranial hemorrhage.
: Source: CSR ENGAGE AF-TIMI 48;⁹ Giugliano, 2013.¹⁰

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Edoxaban (Lixiana) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Apr. APPENDIX 4, DETAILED OUTCOME DATA.