Table 2

Summary of adverse events during study 12 months follow-up period (intention-to-treat population, n=46)

Total number of adverse events (in 44/46 patients)189 (in 96% of patients)
Not DMR-related adverse events* (in 40/46 patients)135 (in 87% of patients)
 GI symptoms
 Such as symptoms occurring before DMR or mild abdominal symptoms weeks after DMR		19
 General symptoms
 Such as injuries, back pain, headache, pruritus, cough		63
 Metabolic symptoms
 Such as hypoglycaemia and hyperglycaemia		21
 Infections
 Such as cystitis, common cold, cellulitis		28
DMR-related adverse events* (in 24/46 patients)54 (in 52% of patients)
 GI symptoms
 Such as diarrhoea, abdominal pain, nausea and oropharyngeal pain		40
 General symptoms
 Such as malaise, fatigue, musculoskeletal pain and rash		11
 Metabolic symptoms
 Such as hypoglycaemia and hyperglycaemia		3
Severity of DMR-related adverse events†54
 Mild44 (81%)
 Moderate10 (19%)
 Severe0 (0%)
Total number of serious adverse events (in 4/46 patients)‡6 (in 9% of patients)

  • *Relationship to DMR was assessed as in terms of not, possibly, probably and definitely based on the temporal association with DMR and the possibility of other aetiologies.

  • †Mild: discomfort but no disruption of daily activity; Moderate: discomfort sufficient to affect daily activity; Severe: inability to perform daily activity.

  • ‡See online supplementary table 1.

  • DMR, duodenal mucosal resurfacing.