Table 3

Device-related/procedure-related adverse events through 24 weeks post procedure (safety population)

EuropeBrazil
DMR N=39Sham N=37DMR N=17Sham N=16
# of eventsn (%)95% CI‡# of eventsn (%)95% CI‡# of eventsn (%)95% CI‡# of eventsn (%)95% CI‡
Summary (through 24 weeks post-treatment)
 SAE00(0.0 to 9.0)00(0.0 to 9.5)32 (11.8)(1.5 to 36.4)00(0.0 to 20.6)
 UADE00(0.0 to 9.0)00(0.0 to 9.5)00(0∙0 to 19.5)00(0.0 to 20.6)
 AESI1913 (33.3)(19.1 to 50.2)1610 (27.0)(13.8 to 44.1)7412 (70.6)(44.0 to 89.7)7610 (62.5)(35.4 to 84.8)
Most common (≥5%) AESIs by preferred term (≤30 days post-treatment)
 Abdominal pain97 (17.9)(7.5 to 33.5)22 (5.4)(0.7 to 18.2)65 (29.4)(10.3 to 56.0)22 (12.5)(1.6 to 38.4)
 Diarrhoea11 (2.6)(0.1 to 13.5)22 (5.4)(0.7 to 18.2)11 (5.9)(0.2 to 28.7)11 (6.3)(0.2 to 30.2)
 Nausea11 (2.6)(0.1 to 13.5)00(0.0 to 9.5)22 (11.8)(1.5 to 36.4)00(0∙0 to 20∙6)
 Vomiting11 (2.6)(0.1 to 13.5)00(0.0 to 9.5)11 (5.9)(0.2 to 28.7)00(0∙0 to 20∙6)
 Hypoglycaemia33 (7.7)(1.62 to 20.9)32 (5.4)(0.7 to 18.2)116 (35.3)(14.2 to 61.7)217 (43.8)(19.8 to 70.1)
Most common (≥5%) AESIs by preferred term (>30 days post-treatment)
 Abdominal pain11 (2.6)(0.1 to 13.5)22 (5∙4)(0.7 to 18.2)00(0.0 to 19.5)00(0.0 to 20.6)
 Hypoglycaemia11 (2.6)(0.1 to 13.5)42 (5∙4)(0.7 to 18.2)535 (29.4)(10.3 to 56.0)528 (50.0)(24.7 to 75.4)
  • Data are presented as n (%), with n as the number of patients with an event.

  • *The primary safety analysis population was defined as all patients in whom the treatment (DMR or sham) was initiated.

  • †European safety population included patients from Italy, UK, Belgium and Netherlands.

  • ‡Two-sided Clopper-Pearson 95% CI of the incidence rates.

  • AESI, adverse event of special interest; DMR, duodenal mucosal resurfacing; SAE, serious adverse event; UADE, unanticipated adverse device effect.