Table 2—

Incidence of severe hypoglycemia and treatment-emergent adverse events with an occurrence ≥10% and the incidence in the pramlintide group at least double that of the placebo group for the double-blind study (weeks 0–52)

PlaceboPramlintide
N237243
Severe hypoglycemia event rate*
 Weeks 0–4*2.00 ± 0.342.12 ± 0.35
 Weeks 4–26*1.37 ± 0.130.74 ± 0.09
 Weeks 26–52*1.24 ± 0.120.43 ± 0.07
Preferred termTotalSevereTotalSevere
 Nausea21.91.746.56.2
 Anorexia§2.10.017.72.5
 Vomiting‖;8.00.411.52.1
  • Data are % or means ± SEM.

  • *

    * Severe hypoglycemia event rate was calculated as the total number of events for all patients on a treatment regimen divided by the total number of patient-years of observation;

  • World Health Organization Adverse Reaction Terminology (WHOART);

  • intensity classified by the investigator;

  • §

    § terms such as a “feeling of fullness” were classified as anorexia;

  • vomiting is included because it maybe related to nausea.