Table 3

Safety data (on-drug)

Liraglutide 3.0 mgPlacebo
n (%)ERn (%)ER
Number of individuals195197
Total AEs180 (92.3)1,139578.3175 (88.8)1,053531.2
Serious AEs16 (8.2)2311.719 (9.6)2512.6
Fatal AEs0 (0.0)00.00 (0.0)00.0
Events leading to treatment discontinuation15 (7.7)178.66 (3.0)63.0
GI AEs121 (62.1)408207.192 (46.7)202101.9
 Nausea58 (29.7)10553.323 (11.7)2713.6
 Constipation28 (14.4)3618.317 (8.6)2110.6
 Diarrhea45 (23.1)7739.130 (15.2)5427.2
 Vomiting32 (16.4)5326.912 (6.1)136.6
 Abdominal discomfort11 (5.6)178.68 (4.1)115.5
Hypoglycemic episodes140 (71.8)1,462742.3140 (71.1)1,859937.9
ADA classified
 Severe3 (1.5)31.52 (1.0)21.0
 Asymptomatic116 (59.5)742376.7116 (58.9)988498.4
 Documented symptomatic92 (47.2)662336.1102 (51.8)816411.7
 Pseudohypoglycemia17 (8.7)4221.314 (7.1)3115.6
 Probable symptomatic8 (4.1)105.118 (9.1)2211.1
 Unclassifiable2 (1.0)31.50 (0.0)00
  • Safety analysis set. Hypoglycemic episodes were classified using ADA criteria and recorded in individual diaries. Data are from individuals on-drug.

  • E, number of events; GI, gastrointestinal; n, number of individuals experiencing at least one event; %, percentage of individuals experiencing at least one event; R, event rate per 100 patient-years of exposure.