Table 2

Adverse events

Frequency (events per participant)
Event classificationMetformin (n=34)Placebo (n=18)p Value
Relationship with study treatment considered at least possible (adverse reactions)
 Non-serious31 (0.91)6 (0.33)0.011
 Serious*3 (0.09)0.199
  Required or prolonged hospital admission3 (0.09)
Relationship with study treatment considered unlikely
 Non-serious23 (0.68)16 (0.89)0.417
 Serious*12 (0.35)3 (0.17)0.366
  Resulted in death3 (0.09)
  Resulted in significant disability or incapacity1 (0.06)
  Required or prolonged hospital admission9 (0.26)2 (0.11)
  • This table presents the frequency of adverse events in each group and, due to the unequal group sizes and the potential for participants to experience more than one adverse event, the event rates per participant. Classification by relatedness and seriousness is based on the designations assigned by local investigators according to the Good Clinical Practice adverse event definitions.

  • *Individual events could have more than one reason for a ‘serious’ designation; in these instances, the event is classified according to the most severe reason specified.