Surrogate endpoint evaluation using data from one large global randomized controlled trial

Table 1 Primary dataset grouping strategy: by-country grouping

Country	Participants (N)	MACE (E)	CV death (E)	Primary analysis	Sensitivity analyses
	Participants (N)	MACE (E)	CV death (E)	(CV deaths per group)
	Total = 9340	Total = 1302	Total = 497	≥ 30	≥ 20	≥ 40
	Total = 9340	Total = 1302	Total = 497	Group identifier
United States of America	2514	389	138	1	1	1
Brazil	939	133	74	2	2	2
South Africa	394	66	39	3	3	3
Poland	388	58	29	4	4	3
United Kingdom	455	79	26	4	5	4
India	401	38	21	5	6	4
Mexico	243	34	21	5	7	5
Romania	252	27	16	6	8	5
Russian Federation	335	27	16	6	8	5
Turkey	323	52	14	7	9	6
Germany	447	50	13	7	9	6
Canada	333	39	11	7	10	6
Spain	205	27	11	8	10	6
Sweden	146	25	10	8	11	7
Finland	132	26	8	8	11	7
Denmark	167	22	7	8	11	7
Austria	119	14	6	9	12	7
Australia	221	37	5	9	12	7
Belgium	77	11	4	9	12	7
France	61	8	4	9	12	7
Italy	203	21	4	9	12	7
Norway	88	22	4	9	13	7
Greece	86	9	3	9	13	7
Serbia	100	8	3	9	13	7
Israel	122	27	2	9	13	7
Republic of Korea	103	4	2	9	13	7
Netherlands	153	14	2	9	13	7
Republic of China, Taiwan	115	10	2	9	13	7
China	92	9	1	9	13	7
Czech Republic	55	6	1	9	13	7
Ireland	40	5	0	9	13	7
United Arab Emirates	31	5	0	9	13	7

Participants were grouped based on country, while ensuring a specified minimum count of CV deaths in each resulting group (30 [default], 20 or 40 CV deaths). First, countries were sorted based on the count of CV deaths in descending order; countries with the same count of CV deaths were ranked alphabetically. Second, starting from the country with most CV deaths (United States of America), countries were grouped iteratively until the count of CV deaths for each group had the reached the specified minimum
CV cardiovascular, E number of events (the first occurrence of the event was considered), N number of participants, MACE major adverse cardiovascular event (three-component composite primary outcome comprising first occurrence of a not-fatal stroke, non-fatal myocardial infarction or CV death)

ISSN: 1472-6947