Table 3.

Adverse events summary: incidences of specific AEs^a with incidence ≥3% in ≥1 treatment group and incidence rates for symptomatic hypoglycaemia up to week 24 (double‐blind period)

Patients, n (%)	Omarigliptin	Sitagliptin	Placebo
	N = 166	N = 164	N = 82
With ≥ 1
AE	83 (50.0)	81 (49.4)	54 (65.9)
Drug‐relatedb AE	7 (4.2)	6 (3.7)	5 (6.1)
SAE	3 (1.8)	3 (1.8)	0 (0.0)
Drug‐relatedb SAE	0 (0.0)	0 (0.0)	0 (0.0)
Patient who died	0 (0.0)	0 (0.0)	0 (0.0)
Who discontinued due to ≥1
AE	1c (0.6)	2 (1.2)	0 (0.0)
Drug‐relatedb AE	1 (0.6)	1 (0.6)	0 (0.0)
SAE	0c (0.0)	1 (0.6)	0 (0.0)
Drug‐relatedb SAE	0 (0.0)	0 (0.0)	0 (0.0)
With specific AEs with incidence ≥3% in ≥1 treatment group, by SOC
Gastrointestinal disorders
Diarrhoea	2 (1.2)	3 (1.8)	3 (3.7)
Gastritis	2 (1.2)	5 (3.0)	0 (0.0)
Infections and infestations
Bronchitis	3 (1.8)	0 (0.0)	3 (3.7)
Influenza	3 (1.8)	5 (3.0)	4 (4.9)
Nasopharyngitis	21 (12.7)	18 (11.0)	25 (30.5)
Pharyngitis	4 (2.4)	4 (2.4)	3 (3.7)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	4 (2.4)	7 (4.3)	2 (2.4)
With ≥1 AE of symptomatic hypoglycaemiad	0 (0.0)	1 (0.6)	0 (0.0)

Abbreviation: SOC, system organ class.

^aAccording to SOC defined by the Medical Dictionary for Regulatory Activities (MedDRA) classification system.

^bAssessed by the investigator as related to study drug.

^cOne additional patient, in whom a SAE of “bile duct stone” was reported, discontinued during the double‐blind period of the study. The patient's discontinuation from study was initially reported as attributable to discontinuation criterion related to increased hepatic enzymes (the elevated hepatic enzymes were not reported as an AE). After unblinding this was updated to indicate that the patient's discontinuation from study was attributable to the SAE; therefore, this patient is not included in this table as discontinued because of an AE/SAE, but is included as discontinued because of an AE/SAE in the week 52 summary (Table S2).

^dPrespecified AE of interest; symptomatic hypoglycaemia: episode with clinical symptoms attributed to hypoglycaemia, without regard to glucose level.