Table 2

Most frequent (≥5%) GI disorders on treatment by preferred term (predefined MedDRA search)

Semaglutide 0.05 mg, n = 64Semaglutide 0.1 mg, n = 63Semaglutide 0.2 mg, n = 65Semaglutide 0.3 mg, n = 63Semaglutide flexible dose, n = 64
N%ERN%ERN%ERN%ERN%ER
GI AEs2132.8611622844.4902363046.21062833454.01012683656.3128322
 Nausea1117.216421219.020521421.522591625.422582539.13485
 Diarrhea710.910261015.913341015.415401625.429771117.22255
 Vomiting69.4102646.3133469.292469.582169.4820
 Constipation23.12546.341069.2112957.971946.3615
 Dyspepsia11.661657.971857.782169.561646.3410
 Abdominal discomfort23.12534.841011.51323.23846.3410
 Abdominal pain23.141123.241034.671957.961646.3718
 Flatulence23.12511.651346.261611.61369.4923
 Abdominal pain, upper011.61346.251346.341169.4820
 Gastroesophageal reflux disease046.382134.63834.83846.3513
Liraglutide 0.3 mg, n = 64Liraglutide 0.6 mg, n = 64Liraglutide 1.2 mg, n = 64Liraglutide 1.8 mg, n = 65Pooled placebo, n = 129
N%ERN%ERN%ERN%ERN%ER
GI AEs1421.925651929.7621612031.3401062741.5812072922.55473
 Nausea69.4718710.91129710.911291320.0184664.779
 Diarrhea57.851357.892357.8821710.815381410.91824
 Vomiting11.613710.9102611.61357.782032.334
 Constipation034.73811.625710.871843.145
 Dyspepsia23.12534.73811.61334.63810.811
 Abdominal discomfort11.61334.751323.12546.2133332.345
 Abdominal pain34.738046.341100
  • E, number of events; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patients experiencing at least one event; R, event rate per 100 years of exposure; %, percentage of patients experiencing at least one event. GI AEs were defined as any of the AEs listed in the table. All AEs, either observed by the investigator or subject, were reported by the investigator and evaluated. The “on treatment” overview includes treatment-emergent AEs with onset at or after the date of the first trial product dose and before or at the date of the last trial product dose plus 7 weeks plus the 7 days’ visit window for the end-of-treatment follow-up visit (56 days). The observation time is the duration of this period.