. 2022 May 9;24(7):1338–1350. doi: 10.1111/dom.14710

TABLE 2.

Adverse events across subgroups in the PIONEER trials

		Patients, N		Patients with ≥1 AE, %		Patients with an AE leading to trial product discontinuation, %		Patients with ≥1 GI AE, %
Subgroup factor	Subgroup	Oral semaglutide ^a	Comparator ^b	Oral semaglutide ^a	Comparator ^b	Oral semaglutide ^a	Comparator ^b	Oral semaglutide ^a	Comparator ^b
Age, y	<65	2519	1451	72.8	71.8	7.5	3.9	36.9	24.5
Age, y	≥65	1058	623	79.1	74.5	13.0	6.0	44.6	22.5
Race ^c	White	2579	1562	74.1	72.1	9.4	4.6	37.9	21.9
	Black/AA	248	146	70.3	72.1	7.3	7.2	37.9	24.9
	Asian	576	269	76.4	72.6	7.5	2.5	42.8	29.6
Ethnicity ^d	H/L	592	370	74.3	71.5	8.7	2.2	38.7	20.2
Ethnicity ^d	Non‐H/L	2903	1681	74.7	72.8	9.2	5.1	39.1	24.5
Duration of diabetes, y	<5	1259	736	70.9	70.3	7.0	4.5	34.5	23.3
	≥5–<10	1087	600	75.5	71.6	9.1	4.0	39.4	23.2
	≥10	1231	738	78.1	75.6	11.2	4.9	44.0	25.1
Baseline BMI, kg/m²	<25	413	187	75.2	73.1	13.5	5.6	44.6	28.2
	≥25–<30	1046	603	76.9	73.9	9.5	5.5	41.5	26.2
	≥30–<35	1086	665	73.6	69.0	8.6	2.8	37.0	20.1
	≥35	1030	619	73.2	75.3	7.6	5.1	36.9	24.5
Baseline HbA1c, %	≤8	1769	1066	75.1	71.6	10.5	4.4	39.8	23.8
	>8–≤9	1221	723	73.1	72.8	8.3	4.4	39.7	23.2
	>9	587	285	77.1	75.3	6.6	5.4	36.2	25.7

Note: Data are the on‐treatment safety analysis set. Percentages are the Cochran–Mantel–Haenszel adjusted proportion of patients.

Abbreviations: AA, African American, AE, adverse event; BMI, body mass index; GI, gastrointestinal, H, Hispanic; HbA1c, glycated haemoglobin; L, Latino; y, years.

^{^a}

Oral semaglutide included data from all three oral semaglutide doses (3, 7 and 14 mg).

^{^b}

Comparators included placebo, empagliflozin 25 mg, sitagliptin 100 mg or liraglutide 1.8 mg, depending on the trial.

^{^c}

Due to local regulations, collection of data on race was not permitted at French and Brazilian trial sites.

^{^d}

Due to local regulations, collection of data on ethnicity was not permitted at French sites.