parallel randomized trial

ATTAIN-2

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

Type 2 diabetes (adults)NCT05872620S000754

Design

Randomized: 1,613
Start year: 2023
Treatment: 72 weeks, follow-up 74 weeks
Countries: Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea, United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults with type 2 diabetes; BMI 27 or higher; HbA1c 7.0 to 10.0 percent

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: randomized
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	diet and exercise alone or up to 3 oral glucose lowering drugs, no DPP-4 inhibitor or GLP-1 receptor agonist; lifestyle: standard	630	630
A2	Orforglipron 6 mg oral once daily 6 mg Orforglipron QD	diet and exercise alone or up to 3 oral glucose lowering drugs, no DPP-4 inhibitor or GLP-1 receptor agonist; lifestyle: standard	329	329
A3	Orforglipron 12 mg oral once daily 12 mg Orforglipron QD	diet and exercise alone or up to 3 oral glucose lowering drugs, no DPP-4 inhibitor or GLP-1 receptor agonist; lifestyle: standard	332	332
A4	Orforglipron 36 mg oral once daily 36 mg Orforglipron QD	diet and exercise alone or up to 3 oral glucose lowering drugs, no DPP-4 inhibitor or GLP-1 receptor agonist; lifestyle: standard	322	322

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Orforglipron 6 mg oral once daily A2	Orforglipron 12 mg oral once daily A3	Orforglipron 36 mg oral once daily A4	Whole trial ALL
age	mean (years)	56.5	56.8	56.2	58.1
age	sd (years)	10.9	10.4	10.5	10.8
asian	n	112	58	55	54
black	n	37	21	19	28
bmi age:<65	mean (kg/m2)	36.1	36.4	36.6	35.6
bmi age:<65	sd (kg/m2)	6.9	7.4	6.3	7.1
bmi age:>=65	mean (kg/m2)	33.7	34.1	34.4	33.9
bmi age:>=65	sd (kg/m2)	4.7	5.3	5.7	5.1
bmi	mean (kg/m2)					35.6
bmi	sd (kg/m2)					6.6
diabetes duration	mean (years)					8.5
diabetes duration	sd (years)					6.6
egfr	mean (mL/min/1.73 m2)					82.8
egfr	sd (mL/min/1.73 m2)					21.5
female	n	298	150	155	154
hba1c age:<65	mean (percent)	8.1	8.1	8.1	8.1
hba1c age:<65	sd (percent)	0.8	0.7	0.8	0.8
hba1c age:>=65	mean (percent)	7.8	7.9	7.9	7.9
hba1c age:>=65	sd (percent)	0.7	0.6	0.6	0.6
hba1c	mean (percent)					8.05
hba1c	sd (percent)					0.75
hispanic	n	194	102	95	97
other race american indian alaska native	n	2	0	2	1
other race multiple	n	22	5	12	6
other race native hawaiian pacific islander	n	3	2	1	0
sbp age:<65	mean (mmHg)	129.9	131.0	131.2	132.2
sbp age:<65	sd (mmHg)	14.6	15.0	14.9	13.8
sbp age:>=65	mean (mmHg)	132.6	132.4	134.8	133.2
sbp age:>=65	sd (mmHg)	12.3	13.9	15.3	13.4
waist age:<65	mean (cm)	115.8	117.4	116.4	114.8
waist age:<65	sd (cm)	15.6	16.0	13.7	16.0
waist age:>=65	mean (cm)	112.6	115.0	115.7	114.3
waist age:>=65	sd (cm)	10.8	11.7	12.6	13.0
waist	mean (cm)					115.6
waist	sd (cm)					14.6
weight	mean (kg)	101.19	102.29	102.71	99.78
weight	sd (kg)	22.62	22.74	21.32	22.99
white	n	442	238	235	228

Analyses this trial contributes to

Results

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

HbA1c change (21 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	-0.14 percent	0.060		630	hypothetical; randomized; registry:outcomes
72	A1	change	-0.16 percent		-0.30 to -0.02	474	hypothetical; randomized; age:<65; R0001832:Table 2
72	A1	change	-0.12 percent		-0.30 to 0.06	156	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A2 vs A1	md	-1.34 percent		-1.58 to -1.10		hypothetical; randomized; age:>=65; R0001832:Table 2
72	A2	change	-1.46 percent		-1.61 to -1.30	78	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A2 vs A1	md	-1.09 percent		-1.31 to -0.87		hypothetical; randomized; age:<65; R0001832:Table 2
72	A2	change	-1.25 percent		-1.42 to -1.08	251	hypothetical; randomized; age:<65; R0001832:Table 2
72	A2 vs A1	md	-1.16 percent		-1.34 to -0.98		hypothetical; randomized; registry:outcomes
72	A2	change	-1.29 percent	0.069		329	hypothetical; randomized; registry:outcomes
72	A3 vs A1	md	-1.45 percent		-1.65 to -1.25		hypothetical; randomized; age:<65; R0001832:Table 2
72	A3	change	-1.60 percent	0.058		332	hypothetical; randomized; registry:outcomes
72	A3 vs A1	md	-1.46 percent		-1.62 to -1.30		hypothetical; randomized; registry:outcomes
72	A3	change	-1.60 percent		-1.74 to -1.47	247	hypothetical; randomized; age:<65; R0001832:Table 2
72	A3	change	-1.62 percent		-1.79 to -1.45	85	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A3 vs A1	md	-1.50 percent		-1.75 to -1.25		hypothetical; randomized; age:>=65; R0001832:Table 2
72	A4	change	-1.83 percent		-1.98 to -1.68	221	hypothetical; randomized; age:<65; R0001832:Table 2
72	A4	change	-1.79 percent	0.059		322	hypothetical; randomized; registry:outcomes
72	A4 vs A1	md	-1.67 percent		-1.88 to -1.46		hypothetical; randomized; age:<65; R0001832:Table 2
72	A4 vs A1	md	-1.65 percent		-1.82 to -1.49		hypothetical; randomized; registry:outcomes
72	A4	change	-1.66 percent		-1.81 to -1.51	101	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A4 vs A1	md	-1.54 percent		-1.78 to -1.30		hypothetical; randomized; age:>=65; R0001832:Table 2

Body weight change in kilograms (diabetes) (14 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	change	-2.3 kg	-2.8 to -1.8	474	hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A1	change	-2.1 kg	-2.9 to -1.3	156	hypothetical; randomized; age:>=65; R0001832:Supplement Table S2
72	A2 vs A1	md	-5.3 kg	-7.2 to -3.4		hypothetical; randomized; age:>=65; R0001832:Supplement Table S2
72	A2	change	-5.1 kg	-5.8 to -4.3	251	hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A2 vs A1	md	-2.7 kg	-3.7 to -1.8		hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A2	change	-7.4 kg	-9.1 to -5.8	78	hypothetical; randomized; age:>=65; R0001832:Supplement Table S2
72	A3	change	-7.8 kg	-8.8 to -6.9	247	hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A3 vs A1	md	-5.9 kg	-7.5 to -4.3		hypothetical; randomized; age:>=65; R0001832:Supplement Table S2
72	A3	change	-8.1 kg	-9.4 to -6.7	85	hypothetical; randomized; age:>=65; R0001832:Supplement Table S2
72	A3 vs A1	md	-5.5 kg	-6.6 to -4.4		hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A4	change	-11.6 kg	-13.2 to -10.0	101	hypothetical; randomized; age:>=65; R0001832:Supplement Table S2
72	A4	change	-9.8 kg	-11.0 to -8.6	221	hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A4 vs A1	md	-7.5 kg	-8.7 to -6.2		hypothetical; randomized; age:<65; R0001832:Supplement Table S2
72	A4 vs A1	md	-9.5 kg	-11.3 to -7.7		hypothetical; randomized; age:>=65; R0001832:Supplement Table S2

HbA1c below 7 percent (7 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	23.0		630	hypothetical; randomized; registry:outcomes
72	A2	responders	70.0		329	hypothetical; randomized; registry:outcomes
72	A2 vs A1	rd	46.99	40.48 to 53.49		hypothetical; randomized; registry:outcomes
72	A3	responders	78.0		332	hypothetical; randomized; registry:outcomes
72	A3 vs A1	rd	55.07	48.89 to 61.25		hypothetical; randomized; registry:outcomes
72	A4	responders	85.1		322	hypothetical; randomized; registry:outcomes
72	A4 vs A1	rd	62.08	56.51 to 67.64		hypothetical; randomized; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 628	not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events
A2	events	1 / 328	not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events
A3	events	0 / 331	not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events
A4	events	0 / 321	not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events

Systolic blood pressure change (1 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	-1.48 mmHg	0.534		630	hypothetical; randomized; registry:outcomes

Percent body weight change (7 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	percent change	-2.21 percent	0.215		630	hypothetical; randomized; registry:outcomes
72	A2	percent change	-5.50 percent	0.356		329	hypothetical; randomized; registry:outcomes
72	A2 vs A1	md	-3.28 percent		-4.10 to -2.47		hypothetical; randomized; registry:outcomes
72	A3	percent change	-7.78 percent	0.411		332	hypothetical; randomized; registry:outcomes
72	A3 vs A1	md	-5.56 percent		-6.48 to -4.65		hypothetical; randomized; registry:outcomes
72	A4	percent change	-10.54 percent	0.466		322	hypothetical; randomized; registry:outcomes
72	A4 vs A1	md	-8.33 percent		-9.34 to -7.32		hypothetical; randomized; registry:outcomes

Weight loss of 5 percent or more (7 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	24.4		630	hypothetical; randomized; registry:outcomes
72	A2	responders	49.8		329	hypothetical; randomized; registry:outcomes
72	A2 vs A1	rd	25.43	18.54 to 32.31		hypothetical; randomized; registry:outcomes
72	A3	responders	60.2		332	hypothetical; randomized; registry:outcomes
72	A3 vs A1	rd	35.79	29.12 to 42.45		hypothetical; randomized; registry:outcomes
72	A4	responders	72.8		322	hypothetical; randomized; registry:outcomes
72	A4 vs A1	rd	48.37	41.95 to 54.80		hypothetical; randomized; registry:outcomes

Weight loss of 10 percent or more (7 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	7.0		630	hypothetical; randomized; registry:outcomes
72	A2	responders	23.9		329	hypothetical; randomized; registry:outcomes
72	A2 vs A1	rd	16.92	11.53 to 22.31		hypothetical; randomized; registry:outcomes
72	A3	responders	35.5		332	hypothetical; randomized; registry:outcomes
72	A3 vs A1	rd	28.50	22.69 to 34.31		hypothetical; randomized; registry:outcomes
72	A4	responders	50.1		322	hypothetical; randomized; registry:outcomes
72	A4 vs A1	rd	43.15	36.86 to 49.45		hypothetical; randomized; registry:outcomes

Weight loss of 15 percent or more (7 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	1.9		630	hypothetical; randomized; registry:outcomes
72	A2	responders	7.3		329	hypothetical; randomized; registry:outcomes
72	A2 vs A1	rd	5.42	2.25 to 8.59		hypothetical; randomized; registry:outcomes
72	A3	responders	17.7		332	hypothetical; randomized; registry:outcomes
72	A3 vs A1	rd	15.78	11.32 to 20.24		hypothetical; randomized; registry:outcomes
72	A4	responders	28.4		322	hypothetical; randomized; registry:outcomes
72	A4 vs A1	rd	26.52	21.27 to 31.76		hypothetical; randomized; registry:outcomes

Acute kidney injury (4 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 628	not stated; safety; acute kidney injury; registry:adverse_events
A2	events	0 / 328	not stated; safety; acute kidney injury; registry:adverse_events
A3	events	2 / 331	not stated; safety; acute kidney injury; registry:adverse_events
A4	events	0 / 321	not stated; safety; acute kidney injury; registry:adverse_events

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	4 / 628	not stated; safety; registry:adverse_events
A2	events	0 / 328	not stated; safety; registry:adverse_events
A3	events	4 / 331	not stated; safety; registry:adverse_events
A4	events	2 / 321	not stated; safety; registry:adverse_events

SF-36 physical component summary change (1 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	0.42 points	0.271		629	hypothetical; randomized; registry:outcomes

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	55 / 628	not stated; safety; registry:adverse_events
A2	events	24 / 328	not stated; safety; registry:adverse_events
A3	events	34 / 331	not stated; safety; registry:adverse_events
A4	events	35 / 321	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	5 / 630	not stated; randomized; registry:flow
A2	events	7 / 329	not stated; randomized; registry:flow
A3	events	6 / 332	not stated; randomized; registry:flow
A4	events	3 / 322	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	53 / 628	not stated; safety; registry:adverse_events
A2	events	66 / 328	not stated; safety; registry:adverse_events
A3	events	103 / 331	not stated; safety; registry:adverse_events
A4	events	117 / 321	not stated; safety; registry:adverse_events

Vomiting (8 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	24 / 628	not stated; safety; registry:adverse_events
A1	events	0 / 628	not stated; safety; registry:adverse_events
A2	events	42 / 328	not stated; safety; registry:adverse_events
A2	events	0 / 328	not stated; safety; registry:adverse_events
A3	events	67 / 331	not stated; safety; registry:adverse_events
A3	events	0 / 331	not stated; safety; registry:adverse_events
A4	events	74 / 321	not stated; safety; registry:adverse_events
A4	events	1 / 321	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	94 / 628	not stated; safety; registry:adverse_events
A2	events	70 / 328	not stated; safety; registry:adverse_events
A3	events	82 / 331	not stated; safety; registry:adverse_events
A4	events	88 / 321	not stated; safety; registry:adverse_events

Constipation (8 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	49 / 628	not stated; safety; registry:adverse_events
A1	events	0 / 628	not stated; safety; registry:adverse_events
A2	events	58 / 328	not stated; safety; registry:adverse_events
A2	events	0 / 328	not stated; safety; registry:adverse_events
A3	events	70 / 331	not stated; safety; registry:adverse_events
A3	events	1 / 331	not stated; safety; registry:adverse_events
A4	events	0 / 321	not stated; safety; registry:adverse_events
A4	events	72 / 321	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (16 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 628	not stated; safety; bile duct stone; registry:adverse_events
A1	events	1 / 628	not stated; safety; acute cholecystitis necrotic; registry:adverse_events
A1	events	1 / 628	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	2 / 628	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 328	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 328	not stated; safety; bile duct stone; registry:adverse_events
A2	events	0 / 328	not stated; safety; acute cholecystitis necrotic; registry:adverse_events
A2	events	0 / 328	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 331	not stated; safety; acute cholecystitis necrotic; registry:adverse_events
A3	events	1 / 331	not stated; safety; cholecystitis acute; registry:adverse_events
A3	events	0 / 331	not stated; safety; bile duct stone; registry:adverse_events
A3	events	2 / 331	not stated; safety; cholelithiasis; registry:adverse_events
A4	events	0 / 321	not stated; safety; acute cholecystitis necrotic; registry:adverse_events
A4	events	1 / 321	not stated; safety; cholecystitis acute; registry:adverse_events
A4	events	1 / 321	not stated; safety; bile duct stone; registry:adverse_events
A4	events	1 / 321	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (8 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 628	not stated; safety; obstructive pancreatitis; registry:adverse_events
A1	events	1 / 628	not stated; safety; pancreatitis acute; registry:adverse_events
A2	events	0 / 328	not stated; safety; obstructive pancreatitis; registry:adverse_events
A2	events	0 / 328	not stated; safety; pancreatitis acute; registry:adverse_events
A3	events	1 / 331	not stated; safety; obstructive pancreatitis; registry:adverse_events
A3	events	0 / 331	not stated; safety; pancreatitis acute; registry:adverse_events
A4	events	0 / 321	not stated; safety; obstructive pancreatitis; registry:adverse_events
A4	events	0 / 321	not stated; safety; pancreatitis acute; registry:adverse_events

Thyroid cancer (any) (4 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 628	not stated; safety; papillary thyroid cancer; registry:adverse_events
A2	events	0 / 328	not stated; safety; papillary thyroid cancer; registry:adverse_events
A3	events	0 / 331	not stated; safety; papillary thyroid cancer; registry:adverse_events
A4	events	0 / 321	not stated; safety; papillary thyroid cancer; registry:adverse_events

Diabetic retinopathy complications (4 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	34 / 628	not stated; safety; diabetic retinopathy; registry:adverse_events
A2	events	15 / 328	not stated; safety; diabetic retinopathy; registry:adverse_events
A3	events	14 / 331	not stated; safety; diabetic retinopathy; registry:adverse_events
A4	events	17 / 321	not stated; safety; diabetic retinopathy; registry:adverse_events

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 628	not stated; safety; suicidal ideation; registry:adverse_events
A2	events	1 / 328	not stated; safety; suicidal ideation; registry:adverse_events
A3	events	0 / 331	not stated; safety; suicidal ideation; registry:adverse_events
A4	events	0 / 321	not stated; safety; suicidal ideation; registry:adverse_events

Intestinal obstruction or ileus (8 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 628	not stated; safety; intestinal obstruction; registry:adverse_events
A1	events	0 / 628	not stated; safety; small intestinal obstruction; registry:adverse_events
A2	events	1 / 328	not stated; safety; intestinal obstruction; registry:adverse_events
A2	events	0 / 328	not stated; safety; small intestinal obstruction; registry:adverse_events
A3	events	0 / 331	not stated; safety; intestinal obstruction; registry:adverse_events
A3	events	1 / 331	not stated; safety; small intestinal obstruction; registry:adverse_events
A4	events	0 / 321	not stated; safety; intestinal obstruction; registry:adverse_events
A4	events	0 / 321	not stated; safety; small intestinal obstruction; registry:adverse_events

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	1 / 628	not stated; safety; pancreatic neoplasm; registry:adverse_events
A2	events	0 / 328	not stated; safety; pancreatic neoplasm; registry:adverse_events
A3	events	0 / 331	not stated; safety; pancreatic neoplasm; registry:adverse_events
A4	events	0 / 321	not stated; safety; pancreatic neoplasm; registry:adverse_events

Any cancer (52 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	1 / 628	not stated; safety; adenocarcinoma of colon; registry:adverse_events
A1	events	1 / 628	not stated; safety; bladder cancer; registry:adverse_events
A1	events	2 / 628	not stated; safety; colorectal adenocarcinoma; registry:adverse_events
A1	events	0 / 628	not stated; safety; gastrointestinal adenocarcinoma; registry:adverse_events
A1	events	0 / 628	not stated; safety; hepatocellular carcinoma; registry:adverse_events
A1	events	1 / 628	not stated; safety; intestinal adenocarcinoma; registry:adverse_events
A1	events	0 / 628	not stated; safety; lentigo maligna; registry:adverse_events
A1	events	0 / 628	not stated; safety; lung adenocarcinoma; registry:adverse_events
A1	events	1 / 628	not stated; safety; pancreatic neoplasm; registry:adverse_events
A1	events	2 / 628	not stated; safety; papillary thyroid cancer; registry:adverse_events
A1	events	0 / 628	not stated; safety; small cell lung cancer; registry:adverse_events
A1	events	0 / 628	not stated; safety; transitional cell carcinoma; registry:adverse_events
A1	events	0 / 628	not stated; safety; urinary tract neoplasm; registry:adverse_events
A2	events	0 / 328	not stated; safety; adenocarcinoma of colon; registry:adverse_events
A2	events	0 / 328	not stated; safety; bladder cancer; registry:adverse_events
A2	events	0 / 328	not stated; safety; colorectal adenocarcinoma; registry:adverse_events
A2	events	1 / 328	not stated; safety; gastrointestinal adenocarcinoma; registry:adverse_events
A2	events	1 / 328	not stated; safety; hepatocellular carcinoma; registry:adverse_events
A2	events	0 / 328	not stated; safety; intestinal adenocarcinoma; registry:adverse_events
A2	events	0 / 328	not stated; safety; lentigo maligna; registry:adverse_events
A2	events	0 / 328	not stated; safety; lung adenocarcinoma; registry:adverse_events
A2	events	0 / 328	not stated; safety; pancreatic neoplasm; registry:adverse_events
A2	events	0 / 328	not stated; safety; papillary thyroid cancer; registry:adverse_events
A2	events	0 / 328	not stated; safety; small cell lung cancer; registry:adverse_events
A2	events	0 / 328	not stated; safety; transitional cell carcinoma; registry:adverse_events
A2	events	0 / 328	not stated; safety; urinary tract neoplasm; registry:adverse_events
A3	events	0 / 331	not stated; safety; adenocarcinoma of colon; registry:adverse_events
A3	events	0 / 331	not stated; safety; bladder cancer; registry:adverse_events
A3	events	0 / 331	not stated; safety; colorectal adenocarcinoma; registry:adverse_events
A3	events	0 / 331	not stated; safety; gastrointestinal adenocarcinoma; registry:adverse_events
A3	events	0 / 331	not stated; safety; hepatocellular carcinoma; registry:adverse_events
A3	events	0 / 331	not stated; safety; intestinal adenocarcinoma; registry:adverse_events
A3	events	0 / 331	not stated; safety; lentigo maligna; registry:adverse_events
A3	events	0 / 331	not stated; safety; lung adenocarcinoma; registry:adverse_events
A3	events	0 / 331	not stated; safety; pancreatic neoplasm; registry:adverse_events
A3	events	0 / 331	not stated; safety; papillary thyroid cancer; registry:adverse_events
A3	events	0 / 331	not stated; safety; small cell lung cancer; registry:adverse_events
A3	events	1 / 331	not stated; safety; transitional cell carcinoma; registry:adverse_events
A3	events	1 / 331	not stated; safety; urinary tract neoplasm; registry:adverse_events
A4	events	0 / 321	not stated; safety; adenocarcinoma of colon; registry:adverse_events
A4	events	0 / 321	not stated; safety; bladder cancer; registry:adverse_events
A4	events	0 / 321	not stated; safety; colorectal adenocarcinoma; registry:adverse_events
A4	events	0 / 321	not stated; safety; gastrointestinal adenocarcinoma; registry:adverse_events
A4	events	0 / 321	not stated; safety; hepatocellular carcinoma; registry:adverse_events
A4	events	0 / 321	not stated; safety; intestinal adenocarcinoma; registry:adverse_events
A4	events	1 / 321	not stated; safety; lentigo maligna; registry:adverse_events
A4	events	1 / 321	not stated; safety; lung adenocarcinoma; registry:adverse_events
A4	events	0 / 321	not stated; safety; pancreatic neoplasm; registry:adverse_events
A4	events	0 / 321	not stated; safety; papillary thyroid cancer; registry:adverse_events
A4	events	1 / 321	not stated; safety; small cell lung cancer; registry:adverse_events
A4	events	0 / 321	not stated; safety; transitional cell carcinoma; registry:adverse_events
A4	events	0 / 321	not stated; safety; urinary tract neoplasm; registry:adverse_events