Table 3. Treatment-Emergent Adverse Events Among Patients With Type 2 Diabetes and Insufficient Glycemic Control^a.

	Placebo Group, No. of Patients (%) [No. of Events] (n = 71)	Oral Semaglutide Groups, No. of Patients (%) [No. of Events]							1-mg SC Semaglutide Group, No. of Patients (%) [No. of Events] (n = 69)
		2.5 mg (n = 70)	Standard Dose Escalationb				Slow Escalationb	Fast Escalationb
			5 mg (n = 70)	10 mg (n = 69)	20 mg (n = 70)	40 mg (n = 71)	40 mg (n = 70)	40 mg (n = 70)
Adverse events	48 (68) [127]	47 (67) [142]	44 (63) [169]	52 (75) [233]	57 (81) [289]	56 (79) [230]	55 (79) [233]	60 (86) [245]	56 (81) [218]
Serious adverse eventsc	5 (7) [8]	1 (1) [1]	2 (3) [2]	2 (3) [5]	NR	1 (1) [1]	3 (4) [3]	5 (7) [9]	2 (3) [2]
Premature treatment discontinuation due to adverse events	1 (1) [2]	6 (9) [7]	4 (6) [6]	8 (12) [16]	19 (27) [42]	16 (23) [30]	10 (14) [22]	18 (26) [35]	10 (14) [20]
Severityd
Severe	2 (3) [4]	1 (1) [1]	2 (3) [2]	6 (9) [19]	6 (9) [8]	5 (7) [9]	7 (10) [9]	6 (9) [8]	4 (6) [5]
Moderate	17 (24) [25]	23 (33) [35]	18 (26) [41]	26 (38) [64]	32 (46) [79]	32 (45) [83]	28 (40) [72]	31 (44) [70]	29 (42) [65]
Mild	46 (65) [98]	36 (51) [106]	39 (56) [126]	44 (64) [150]	48 (69) [202]	47 (66) [138]	47 (67) [152]	49 (70) [167]	46 (67) [148]
Gastrointestinal adverse events reported in ≥5% of patients
All gastrointestinal adverse events	20 (28) [32]	22 (31) [44]	22 (31) [49]	37 (54) [101]	39 (56) [127]	43 (61) [128]	38 (54) [116]	54 (77) [111]	37 (54) [86]
Nausea	1 (1) [1]	9 (13) [12]	10 (14) [13]	23 (33) [28]	24 (34) [36]	24 (34) [37]	23 (33) [29]	26 (37) [28]	22 (32) [23]
Vomiting	3 (4) [3]	4 (6) [8]	4 (6) [5]	15 (22) [19]	11 (16) [14]	14 (20) [25]	11 (16) [22]	17 (24) [21]	6 (9) [6]
Dyspepsia	3 (4) [3]	2 (3) [6]	5 (7) [7]	6 (9) [6]	8 (11) [8]	6 (8) [8]	6 (9) [8]	5 (7) [5]	10 (14) [11]
Abdominal distension	5 (7) [5]	NR	3 (4) [3]	1 (1) [1]	2 (3) [2]	6 (8) [6]	1 (1) [1]	3 (4) [3]	3 (4) [4]
Abdominal pain	NR	3 (4) [3]	1 (1) [1]	1 (1) [1]	4 (6) [7]	3 (4) [3]	4 (6) [4]	3 (4) [3]	4 (6) [4]
Abdominal discomfort	NR	NR	1 (1) [1]	2 (3) [2]	3 (4) [3]	2 (3) [2]	1 (1) [1]	4 (6) [5]	5 (7) [7]
Abdominal pain upper	NR	NR	2 (3) [2]	1 (1) [1]	6 (9) [8]	2 (3) [2]	4 (6) [6]	1 (1) [1]	NR
Eructation	NR	NR	NR	1 (1) [1]	2 (3) [2]	5 (7) [5]	1 (1) [1]	2 (3) [2]	2 (3) [2]
Diarrhea	7 (10) [10]	5 (7) [6]	7 (10) [7]	16 (23) [20]	14 (20) [18]	10 (14) [15]	14 (20) [27]	13 (19) [16]	10 (14) [14]
Constipation	4 (6) [5]	4 (6) [4]	4 (6) [4]	6 (9) [8]	5 (7) [8]	9 (13) [11]	7 (10) [7]	8 (11) [9]	7 (10) [7]
Gastroesophageal reflux disease	1 (1) [1]	2 (3) [2]	2 (3) [2]	4 (6) [4]	5 (7) [7]	4 (6) [4]	4 (6) [4]	4 (6) [4]	1 (1) [1]

Abbreviations: NR, none reported; SC, subcutaneous.

^aTreatment-emergent adverse events were defined as events that had an onset, or increase in severity, on or after the first day of exposure to the follow-up visit scheduled 5 weeks (plus 5-day visit window) after last trial product dose or the patient’s end-of-trial date, depending on which was encountered first. All adverse events were coded using the Medical Dictionary for Regulatory Activities, edition 17.1. No fatal events were reported.

^bStandard escalation indicates 4-week intervals; slow escalation, 8-week intervals; fast escalation, 2-week intervals.

^cA serious adverse event was defined as an experience that at any dose results in any of the following: death; a life-threatening experience; in-patient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; or a situation in which medical judgment deems that medical or surgical intervention is necessary to prevent 1 of the outcomes listed in this definition of serious adverse events.

^dSeverity of adverse events was defined as follows: mild (transient symptoms, no interference with daily activities); moderate (marked symptoms, moderate interference with daily activities); severe (considerable interference with daily activities, unacceptable).