Table 3

On-treatment adverse events

Oral semaglutide 3 mg (n = 175)Oral semaglutide 7 mg (n = 175)Oral semaglutide 14 mg (n = 175)Placebo (n = 178)
Any adverse event101 (57.7)93 (53.1)99 (56.6)99 (55.6)
Severity
 Severe8 (4.6)1 (0.6)3 (1.7)5 (2.8)
 Moderate40 (22.9)29 (16.6)34 (19.4)47 (26.4)
 Mild89 (50.9)84 (48.0)81 (46.3)81 (45.5)
Severe or blood glucose–confirmed symptomatic hypoglycemic episode*5 (2.9)2 (1.1)1 (0.6)1 (0.6)
Severe hypoglycemic episodes*01 (0.6)00
Most frequent adverse events >5% in any group (preferred term)
 Nausea14 (8.0)9 (5.1)28 (16.0)10 (5.6)
 Diarrhea15 (8.6)9 (5.1)9 (5.1)4 (2.2)
 Vomiting5 (2.9)8 (4.6)12 (6.9)4 (2.2)
 Nasopharyngitis10 (5.7)11 (6.3)3 (1.7)6 (3.4)
 Influenza9 (5.1)5 (2.9)4 (2.3)2 (1.1)
 Headache6 (3.4)10 (5.7)9 (5.1)9 (5.1)
 Decreased appetite2 (1.1)3 (1.7)9 (5.1)1 (0.6)
Serious adverse events5 (2.9)3 (1.7)2 (1.1)8 (4.5)
Adverse events leading to premature trial product discontinuation4 (2.3)7 (4.0)13 (7.4)4 (2.2)
Adverse events leading to premature trial product discontinuation (>3% in any system organ class)§
 Gastrointestinal disorders3 (1.7)4 (2.3)9 (5.1)1 (0.6)
Deaths0000
  • Data are n (%). SI conversion factor: to convert glucose to mmol/L, multiply by 0.055494. “On-treatment”: the period when the patient is considered treated with trial product.

  • *Hypoglycemic episodes were reported on a form separate from that used for adverse events.

  • †Severe hypoglycemia was defined according to the American Diabetes Association classification (16) (requiring assistance of another person to actively administer carbohydrate or glucagon or take other corrective actions). There was one case of severe nocturnal hypoglycemia, which occurred in a patient in the oral semaglutide 7 mg group.

  • ‡Blood glucose confirmation of symptomatic hypoglycemia was based on a blood glucose value <56 mg/dL with symptoms consistent with hypoglycemia.

  • §There were no more than n = 3 (1.7%) adverse events leading to premature trial product discontinuation by any one preferred term in any treatment group.

  • ‖One patient died (cardiogenic shock with onset 42 days after discontinuing treatment due to other adverse events [decreased appetite and weight loss]).