parallel randomized trial

SELECT

SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

Overweight or obesity without diabetes (adults)NCT03574597S000716

Design

Randomized: 17,604
Start year: 2018
Treatment: , follow-up 256.36 weeks
Countries: multinational (804 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 45 or older; BMI 27 or higher; established CVD; no diabetes; HbA1c below 6.5 percent

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: censoring at withdrawal for events; multiple imputation for continuous endpoints

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	standard care for cardiovascular disease; lifestyle: standard	8,803	8,803
A2	Placebo Placebo	standard care for cardiovascular disease; lifestyle: standard	8,801	8,801

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Semaglutide 2.4 mg subcutaneous once weekly A1	Placebo A2	Whole trial ALL
age	mean (years)	61.6	61.6
age	sd (years)	8.9	8.8
asian	n	720	727
asian	percent	8.2	8.3
black	n	348	323
black	percent	4.0	3.7
bmi: 30 or more	n			12580
bmi: 30 or more	percent			71.5
bmi	mean (kg/m2)	33.3	33.4
bmi	sd (kg/m2)	5.0	5.0
egfr	mean (mL/min/1.73 m2)	82.4	82.5
egfr	sd (mL/min/1.73 m2)	17.5	17.3
established cvd: cerebrovascular disorder	n			1176
established cvd: cerebrovascular disorder	percent			6.7
established cvd: coronary heart disease	n			14452
established cvd: coronary heart disease	percent			82.1
established cvd: mi only	n	5962	5944
established cvd: mi only	percent	67.7	67.5
established cvd: other	n	169	181
established cvd: other	percent	1.9	2.1
established cvd: pad only	n	376	401
established cvd: pad only	percent	4.3	4.6
established cvd: stroke only	n	1578	1556
established cvd: stroke only	percent	17.9	17.7
established cvd: stroke	n			4110
established cvd: stroke	percent			23.3
established cvd: two or more criteria	n	718	719
established cvd: two or more criteria	percent	8.2	8.2
female	n	2448	2424
hba1c: 5.7 or more	n	5877	5819
hba1c: 5.7 or more	percent	66.8	66.1
hba1c: less than 5.7	n	2925	2980
hba1c: less than 5.7	percent	33.2	33.9
hba1c	mean (percent)	5.78	5.78
hba1c	sd (percent)	0.34	0.33
hispanic	n	914	908
hispanic	percent	10.4	10.3
other race american indian alaska native	n	23	21
other race native hawaiian pacific islander	n	3	5
other race other	n	253	273
other race other	percent	2.9	3.1
other region: asia	n			2201
other region: asia	percent			12.5
other region: europe	n			6692
other region: europe	percent			38.0
other region: north america	n			4401
other region: north america	percent			25.0
other region: other	n			4310
other region: other	percent			24.5
sbp	mean (mmHg)	131.0	130.9
sbp	sd (mmHg)	15.6	15.3
waist	mean (cm)	111.3	111.4
waist	sd (cm)	13.1	13.1
weight	mean (kg)	96.5	96.8
weight	sd (kg)	17.5	17.8
white	n	7387	7404
white	percent	83.9	84.1

Results

235 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1 vs A2	md	-3.31 mmHg		-3.75 to -2.88		treatment policy; full analysis; R0008068:Table 3
104	A1	change	-3.82 mmHg	0.16		8803	treatment policy; full analysis; R0008068:Table 3
104	A2	change	-0.51 mmHg	0.16		8801	treatment policy; full analysis; R0008068:Table 3
104	A2	change	-0.6 mmHg	16.0		7385	treatment policy; full analysis; registry:outcomes

Percent body weight change (14 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1 vs A2	md	-7.27 percent		-8.09 to -6.46		treatment policy; full analysis; race:asian; R0018713:Results
104	A1	percent change	-9.39 percent	0.09		8803	treatment policy; full analysis; R0008068:Table 3
104	A1 vs A2	md	-8.51 percent		-8.75 to -8.27		treatment policy; full analysis; R0008068:Table 3
104	A1 vs A2	md	-7.30 percent		-7.97 to -6.62		treatment policy; full analysis; region:asia; R0018713:Results
104	A1 vs A2	md	-11.1 percent		-11.56 to -10.66		treatment policy; full analysis; sex:female; R0018713:Results
104	A1 vs A2	md	-7.5 percent		-7.78 to -7.23		treatment policy; full analysis; sex:male; R0018713:Results
104	A2	percent change	-0.87 percent	6.08		7378	treatment policy; full analysis; registry:outcomes
104	A2	percent change	-0.88 percent	0.08		8801	treatment policy; full analysis; R0008068:Table 3
208	A1	percent change	-10.2 percent				treatment policy; full analysis; R0018713:Results
208	A1 vs A2	md	-10.2 percent		-11.0 to -9.42		while on treatment; full analysis; R0018713:Results
208	A1	percent change	-11.7 percent				while on treatment; full analysis; R0018713:Results
208	A1 vs A2	md	-8.7 percent		-9.42 to -7.88		treatment policy; full analysis; R0018713:Results
208	A2	percent change	-1.5 percent				treatment policy; full analysis; R0018713:Results
208	A2	percent change	-1.5 percent				while on treatment; full analysis; R0018713:Results

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1	responders	67.8			8803	treatment policy; full analysis; R0018713:Results
104	A2	responders	21.3			8801	treatment policy; full analysis; R0018713:Results

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1	responders	44.2			8803	treatment policy; full analysis; R0018713:Results
104	A2	responders	6.9			8801	treatment policy; full analysis; R0018713:Results

Weight loss of 15 percent or more (2 lines; O11C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1	responders	22.9			8803	treatment policy; full analysis; R0018713:Results
104	A2	responders	1.7			8801	treatment policy; full analysis; R0018713:Results

Weight loss of 20 percent or more (2 lines; O11D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1	responders	11.0			8803	treatment policy; full analysis; R0018713:Results
104	A2	responders	0.6			8801	treatment policy; full analysis; R0018713:Results

Weight loss of 25 percent or more (2 lines; O11E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1	responders	4.9			8803	treatment policy; full analysis; R0018713:Results
104	A2	responders	0.1			8801	treatment policy; full analysis; R0018713:Results

Acute kidney injury (6 lines; O121)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		171 / 8803	treatment policy; full analysis; R0008068:Table 4
A1	events	1.4	8803	treatment policy; full analysis; R0017609:Results
A1	events		79 / 8803	treatment policy; full analysis; R0017609:Figure 1
A2	events		200 / 8801	treatment policy; full analysis; R0008068:Table 4
A2	events		105 / 8801	treatment policy; full analysis; R0017609:Figure 1
A2	events	1.7	8801	treatment policy; full analysis; R0017609:Results

Progression to type 2 diabetes (5 lines; O14)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1 vs A2	hr	0.27	0.24 to 0.31		treatment policy; full analysis; R0008068:Table 2
A1	cuminc	1.5			treatment policy; full analysis; R0018858:Results
A1	events			306 / 8800	treatment policy; full analysis; R0008068:Table 2
A2	events			1059 / 8797	treatment policy; full analysis; R0008068:Table 2
A2	cuminc	6.9			treatment policy; full analysis; R0018858:Results

All cause mortality (5 lines; O20)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			375 / 8803	treatment policy; full analysis; R0008068:Table 2
A1	events			371 / 8803	not stated; safety; registry:adverse_events
A1 vs A2	hr	0.81	0.71 to 0.93		treatment policy; full analysis; R0008068:Table 2
A2	events			458 / 8801	treatment policy; full analysis; R0008068:Table 2
A2	events			460 / 8801	not stated; safety; registry:adverse_events

Three point MACE (7 lines; O21)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1 vs A2	hr	0.80	0.72 to 0.89		treatment policy; full analysis; registry:outcomes
A1	events			710 / 8803	treatment policy; full analysis; R0008068:Table 2
A1 vs A2	hr	0.80	0.72 to 0.88		treatment policy; full analysis; R0008068:Table 2
A1	events			569 / 8803	treatment policy; full analysis; R0008068:Table 2
A1 vs A2	hr	0.80	0.72 to 0.90		treatment policy; full analysis; R0008068:Table 2
A2	events			701 / 8801	treatment policy; full analysis; R0008068:Table 2
A2	events			877 / 8801	treatment policy; full analysis; R0008068:Table 2

Kidney composite including cardiovascular death (1 lines; O22D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	hr	0.82		0.69 to 0.97		treatment policy; full analysis; R0019766:Results

Kidney composite including albuminuria or smaller eGFR declines (4 lines; O22E)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			155 / 8803	treatment policy; full analysis; R0008068:Table 2
A1 vs A2	hr	0.78	0.63 to 0.96		treatment policy; full analysis; R0008068:Table 2
A1 vs A2	hr	0.75	0.59 to 0.94		while on treatment; other; R0019766:Results
A2	events			198 / 8801	treatment policy; full analysis; R0008068:Table 2

Hospitalization for heart failure (8 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	23 / 8803	not stated; safety; cardiac failure chronic; registry:adverse_events
A1	events	32 / 8803	not stated; safety; cardiac failure acute; registry:adverse_events
A1	events	31 / 8803	not stated; safety; cardiac failure congestive; registry:adverse_events
A1	events	88 / 8803	treatment policy; full analysis; cardiac failure; R0017609:Figure 1
A2	events	36 / 8801	not stated; safety; cardiac failure congestive; registry:adverse_events
A2	events	44 / 8801	not stated; safety; cardiac failure acute; registry:adverse_events
A2	events	28 / 8801	not stated; safety; cardiac failure chronic; registry:adverse_events
A2	events	113 / 8801	treatment policy; full analysis; cardiac failure; R0017609:Figure 1

Heart failure events (6 lines; O23B)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1 vs A2	hr	0.82	0.71 to 0.96		treatment policy; full analysis; R0008068:Table 2
A1	events			300 / 8803	treatment policy; full analysis; R0008068:Table 2
A1	events			97 / 8803	treatment policy; full analysis; R0008068:Table 2
A1 vs A2	hr	0.79	0.60 to 1.03		treatment policy; full analysis; R0008068:Table 2
A2	events			361 / 8801	treatment policy; full analysis; R0008068:Table 2
A2	events			122 / 8801	treatment policy; full analysis; R0008068:Table 2

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A1 vs A2	md	0.01 points		0.01 to 0.02		treatment policy; full analysis; R0008068:Table 3
104	A1	change	0.01 points	0.00		8803	treatment policy; full analysis; R0008068:Table 3
104	A2	change	-0.01 points	0.00		8801	treatment policy; full analysis; R0008068:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2941 / 8803	treatment policy; full analysis; R0008068:Table 4
	A2	events				3204 / 8801	treatment policy; full analysis; R0008068:Table 4

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		1461 / 8803	treatment policy; full analysis; R0008068:Table 4
A1	events	3.6	8803	treatment policy; full analysis; R0017609:Results
A2	events		718 / 8801	treatment policy; full analysis; R0008068:Table 4
A2	events	4.1	8801	treatment policy; full analysis; R0017609:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1592 / 8803	not stated; safety; registry:adverse_events
A1	events	12 / 8803	not stated; safety; registry:adverse_events
A2	events	337 / 8801	not stated; safety; registry:adverse_events
A2	events	8 / 8801	not stated; safety; registry:adverse_events

Vomiting (6 lines; O27B)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	0.2	8803	treatment policy; full analysis; R0017609:Results
A1	events		576 / 8803	not stated; safety; registry:adverse_events
A1	events		18 / 8803	not stated; safety; registry:adverse_events
A2	events	0.1	8801	treatment policy; full analysis; R0017609:Results
A2	events		12 / 8801	not stated; safety; registry:adverse_events
A2	events		87 / 8801	not stated; safety; registry:adverse_events

Diarrhea (8 lines; O27C)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		1 / 8803	not stated; safety; diarrhoea haemorrhagic; registry:adverse_events
A1	events		933 / 8803	not stated; safety; registry:adverse_events
A1	events	0.3	8803	treatment policy; full analysis; R0017609:Results
A1	events		23 / 8803	not stated; safety; registry:adverse_events
A2	events		353 / 8801	not stated; safety; registry:adverse_events
A2	events		16 / 8801	not stated; safety; registry:adverse_events
A2	events		0 / 8801	not stated; safety; diarrhoea haemorrhagic; registry:adverse_events
A2	events	0.2	8801	treatment policy; full analysis; R0017609:Results

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	715 / 8803	not stated; safety; registry:adverse_events
A1	events	8 / 8803	not stated; safety; registry:adverse_events
A2	events	6 / 8801	not stated; safety; registry:adverse_events
A2	events	231 / 8801	not stated; safety; registry:adverse_events

Discontinuation due to gastrointestinal adverse events (14 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	880 / 8803	treatment policy; full analysis; R0008068:Table 4
A1	events	44 / 8803	treatment policy; full analysis; abdominal pain; R0017609:Table 1
A1	events	81 / 8803	treatment policy; full analysis; constipation; R0017609:Table 1
A1	events	207 / 8803	treatment policy; full analysis; diarrhea; R0017609:Table 1
A1	events	77 / 8803	treatment policy; full analysis; dyspepsia; R0017609:Table 1
A1	events	378 / 8803	treatment policy; full analysis; nausea; R0017609:Table 1
A1	events	126 / 8803	treatment policy; full analysis; vomiting; R0017609:Table 1
A2	events	172 / 8801	treatment policy; full analysis; R0008068:Table 4
A2	events	13 / 8801	treatment policy; full analysis; abdominal pain; R0017609:Table 1
A2	events	15 / 8801	treatment policy; full analysis; constipation; R0017609:Table 1
A2	events	32 / 8801	treatment policy; full analysis; diarrhea; R0017609:Table 1
A2	events	9 / 8801	treatment policy; full analysis; dyspepsia; R0017609:Table 1
A2	events	35 / 8801	treatment policy; full analysis; nausea; R0017609:Table 1
A2	events	6 / 8801	treatment policy; full analysis; vomiting; R0017609:Table 1

Gallbladder and biliary disease (44 lines; O28)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		1 / 8803	not stated; safety; cholangitis acute; registry:adverse_events
A1	events		0 / 8803	not stated; safety; biliary colic; registry:adverse_events
A1	events		1 / 8803	not stated; safety; biliary obstruction; registry:adverse_events
A1	events		1 / 8803	not stated; safety; cholangitis infective; registry:adverse_events
A1	events		6 / 8803	not stated; safety; cholangitis; registry:adverse_events
A1	events		1 / 8803	not stated; safety; gallbladder cholesterolosis; registry:adverse_events
A1	events		1 / 8803	not stated; safety; gallbladder disorder; registry:adverse_events
A1	events		1 / 8803	not stated; safety; gallbladder necrosis; registry:adverse_events
A1	events		2 / 8803	not stated; safety; gallbladder polyp; registry:adverse_events
A1	events		2 / 8803	not stated; safety; gallbladder rupture; registry:adverse_events
A1	events		2 / 8803	not stated; safety; hyperplastic cholecystopathy; registry:adverse_events
A1	events		27 / 8803	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events		10 / 8803	not stated; safety; cholecystitis chronic; registry:adverse_events
A1	events		4 / 8803	not stated; safety; cholecystitis infective; registry:adverse_events
A1	events		13 / 8803	not stated; safety; cholecystitis; registry:adverse_events
A1	events	0.56	8803	treatment policy; full analysis; R0017609:Results
A1	events		16 / 8803	not stated; safety; bile duct stone; registry:adverse_events
A1	events		1 / 8803	not stated; safety; cholelithiasis migration; registry:adverse_events
A1	events		1 / 8803	not stated; safety; cholelithiasis obstructive; registry:adverse_events
A1	events		44 / 8803	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	1.4	8803	treatment policy; full analysis; cholelithiasis; R0017609:Results
A1	events		246 / 8803	treatment policy; full analysis; R0008068:Table 4
A2	events		0 / 8801	not stated; safety; gallbladder polyp; registry:adverse_events
A2	events		4 / 8801	not stated; safety; cholecystitis chronic; registry:adverse_events
A2	events		1 / 8801	not stated; safety; biliary colic; registry:adverse_events
A2	events		31 / 8801	not stated; safety; cholelithiasis; registry:adverse_events
A2	events		1 / 8801	not stated; safety; cholangitis acute; registry:adverse_events
A2	events	1.1	8801	treatment policy; full analysis; cholelithiasis; R0017609:Results
A2	events		1 / 8801	not stated; safety; biliary obstruction; registry:adverse_events
A2	events		203 / 8801	treatment policy; full analysis; R0008068:Table 4
A2	events		1 / 8801	not stated; safety; gallbladder rupture; registry:adverse_events
A2	events		30 / 8801	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events		0 / 8801	not stated; safety; hyperplastic cholecystopathy; registry:adverse_events
A2	events		4 / 8801	not stated; safety; cholecystitis infective; registry:adverse_events
A2	events		15 / 8801	not stated; safety; cholecystitis; registry:adverse_events
A2	events		0 / 8801	not stated; safety; gallbladder necrosis; registry:adverse_events
A2	events	0.59	8801	treatment policy; full analysis; R0017609:Results
A2	events		1 / 8801	not stated; safety; gallbladder disorder; registry:adverse_events
A2	events		0 / 8801	not stated; safety; gallbladder cholesterolosis; registry:adverse_events
A2	events		4 / 8801	not stated; safety; cholangitis; registry:adverse_events
A2	events		1 / 8801	not stated; safety; cholangitis infective; registry:adverse_events
A2	events		10 / 8801	not stated; safety; bile duct stone; registry:adverse_events
A2	events		0 / 8801	not stated; safety; cholelithiasis migration; registry:adverse_events
A2	events		1 / 8801	not stated; safety; cholelithiasis obstructive; registry:adverse_events

Acute pancreatitis (14 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	17 / 8803	treatment policy; full analysis; R0008068:Table 4
A1	events	29 / 8803	treatment policy; full analysis; pancreatitis; R0008068:Table 4
A1	events	0 / 8803	not stated; safety; pancreatitis relapsing; registry:adverse_events
A1	events	5 / 8803	not stated; safety; pancreatitis; registry:adverse_events
A1	events	9 / 8803	not stated; safety; registry:adverse_events
A1	events	4 / 8803	not stated; safety; obstructive pancreatitis; registry:adverse_events
A1	events	1 / 8803	not stated; safety; oedematous pancreatitis; registry:adverse_events
A2	events	24 / 8801	treatment policy; full analysis; R0008068:Table 4
A2	events	14 / 8801	not stated; safety; registry:adverse_events
A2	events	7 / 8801	not stated; safety; obstructive pancreatitis; registry:adverse_events
A2	events	1 / 8801	not stated; safety; oedematous pancreatitis; registry:adverse_events
A2	events	1 / 8801	not stated; safety; pancreatitis relapsing; registry:adverse_events
A2	events	3 / 8801	not stated; safety; pancreatitis; registry:adverse_events
A2	events	30 / 8801	treatment policy; full analysis; pancreatitis; R0008068:Table 4

Medullary thyroid carcinoma (4 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8803	treatment policy; full analysis; R0017609:Results
A1	events	0 / 8803	not stated; safety; registry:adverse_events
A2	events	3 / 8801	treatment policy; full analysis; R0017609:Results
A2	events	2 / 8801	not stated; safety; registry:adverse_events

Thyroid cancer (any) (12 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8803	not stated; safety; medullary thyroid cancer; registry:adverse_events
A1	events	4 / 8803	not stated; safety; papillary thyroid cancer; registry:adverse_events
A1	events	5 / 8803	not stated; randomized; R0000453:Table 1
A1	events	0 / 8803	not stated; safety; registry:adverse_events
A1	events	2 / 8803	not stated; safety; follicular thyroid cancer; registry:adverse_events
A1	events	6 / 8803	treatment policy; full analysis; R0017609:Results
A2	events	1 / 8801	not stated; safety; registry:adverse_events
A2	events	0 / 8801	not stated; safety; follicular thyroid cancer; registry:adverse_events
A2	events	2 / 8801	not stated; safety; medullary thyroid cancer; registry:adverse_events
A2	events	2 / 8801	not stated; safety; papillary thyroid cancer; registry:adverse_events
A2	events	8 / 8801	treatment policy; full analysis; R0017609:Results
A2	events	5 / 8801	not stated; randomized; R0000453:Table 1

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 8803	not stated; safety; optic ischaemic neuropathy; registry:adverse_events
	A2	events				1 / 8801	not stated; safety; optic ischaemic neuropathy; registry:adverse_events

Suicidal ideation or behavior (10 lines; O35A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		1 / 8803	treatment policy; full analysis; suicide attempt; R0017609:Supplement Table S3
A1	events		0 / 8803	not stated; safety; depression suicidal; registry:adverse_events
A1	events	0.11	8803	treatment policy; full analysis; R0017609:Abstract
A1	events		10 / 8803	treatment policy; full analysis; R0017609:Supplement Table S3
A1	events		4 / 8803	treatment policy; full analysis; suicidal ideation; R0017609:Supplement Table S3
A2	events	0.11	8801	treatment policy; full analysis; R0017609:Abstract
A2	events		1 / 8801	not stated; safety; depression suicidal; registry:adverse_events
A2	events		9 / 8801	treatment policy; full analysis; R0017609:Supplement Table S3
A2	events		4 / 8801	treatment policy; full analysis; suicidal ideation; R0017609:Supplement Table S3
A2	events		3 / 8801	treatment policy; full analysis; suicide attempt; R0017609:Supplement Table S3

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	5 / 8803	treatment policy; full analysis; R0017609:Results
A1	events	5 / 8803	treatment policy; full analysis; R0017609:Supplement Table S3
A2	events	3 / 8801	treatment policy; full analysis; R0017609:Results
A2	events	2 / 8801	treatment policy; full analysis; R0017609:Supplement Table S3

Intestinal obstruction or ileus (18 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	10 / 8803	not stated; safety; small intestinal obstruction; registry:adverse_events
A1	events	0 / 8803	not stated; safety; ileus paralytic; registry:adverse_events
A1	events	11 / 8803	not stated; safety; intestinal obstruction; registry:adverse_events
A1	events	0 / 8803	not stated; safety; intestinal pseudo-obstruction; registry:adverse_events
A1	events	2 / 8803	not stated; safety; large intestinal obstruction; registry:adverse_events
A1	events	1 / 8803	not stated; safety; mechanical ileus; registry:adverse_events
A1	events	0 / 8803	not stated; safety; subileus; registry:adverse_events
A1	events	29 / 8803	treatment policy; full analysis; R0017609:Results
A1	events	3 / 8803	treatment policy; full analysis; ileus; R0017609:Results
A2	events	1 / 8801	not stated; safety; intestinal pseudo-obstruction; registry:adverse_events
A2	events	0 / 8801	not stated; safety; large intestinal obstruction; registry:adverse_events
A2	events	0 / 8801	not stated; safety; mechanical ileus; registry:adverse_events
A2	events	10 / 8801	not stated; safety; small intestinal obstruction; registry:adverse_events
A2	events	4 / 8801	not stated; safety; subileus; registry:adverse_events
A2	events	29 / 8801	treatment policy; full analysis; R0017609:Results
A2	events	2 / 8801	treatment policy; full analysis; ileus; R0017609:Results
A2	events	2 / 8801	not stated; safety; ileus paralytic; registry:adverse_events
A2	events	8 / 8801	not stated; safety; intestinal obstruction; registry:adverse_events

Pancreatic cancer (10 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	8 / 8803	treatment policy; full analysis; R0017609:Results
A1	events	2 / 8803	not stated; safety; registry:adverse_events
A1	events	0 / 8803	not stated; safety; ductal adenocarcinoma of pancreas; registry:adverse_events
A1	events	3 / 8803	not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events
A1	events	2 / 8803	not stated; safety; adenocarcinoma pancreas; registry:adverse_events
A2	events	1 / 8801	not stated; safety; registry:adverse_events
A2	events	11 / 8801	treatment policy; full analysis; R0017609:Results
A2	events	5 / 8801	not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events
A2	events	1 / 8801	not stated; safety; ductal adenocarcinoma of pancreas; registry:adverse_events
A2	events	2 / 8801	not stated; safety; adenocarcinoma pancreas; registry:adverse_events

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				422 / 8803	treatment policy; full analysis; R0008068:Table 4
	A2	events				418 / 8801	treatment policy; full analysis; R0008068:Table 4