TABLE 3.
Treatment‐emergent serious adverse events (by SOC and occurring in ≥1% of patients in any group)
| Liraglutide | OAD a | |||||||
|---|---|---|---|---|---|---|---|---|
| N | % | E | R | N | % | E | R | |
| Total | 92 | 9.4 | 145 | 107.0 | 81 | 8.2 | 140 | 111.2 |
| Cardiac disorders | 20 | 2.0 | 24 | 17.7 | 17 | 1.7 | 23 | 18.3 |
| Infections and infestations | 14 | 1.4 | 16 | 11.8 | 15 | 1.5 | 20 | 15.9 |
| Gastrointestinal disorders | 9 | 0.9 | 10 | 7.4 | 10 | 1.0 | 14 | 11.1 |
| Neoplasms (benign, malignant, and unspecified [including cysts and polyps]) | 9 | 0.9 | 10 | 7.4 | 10 | 1.0 | 10 | 7.9 |
| Nervous system disorders | 10 | 1.0 | 12 | 8.9 | 8 | 0.8 | 10 | 7.9 |
| Renal and urinary disorders | 11 | 1.1 | 13 | 9.6 | 7 | 0.7 | 9 | 7.2 |
Abbreviations: E, number of events; N, number of patients with ≥1 event; OAD, oral antidiabetic drug; R, rate (number of events divided by patient‐years of exposure multiplied by 1000); SOC, system organ class; %, percentage of patients with ≥1 event.
OADs included investigator‐selected drugs from the classes: α‐glucosidase inhibitor, dipeptidyl peptidase‐4 inhibitor, sodium‐glucose co‐transporter‐2 inhibitor, sulphonylurea, or thiazolidinedione; both liraglutide and OADs were prescribed in combination with metformin. Safety analysis set. Treatment‐emergent adverse event: defined as an event with an onset date (or increase in severity) on or after the first day of trial product administration and no later than 7 days after the last trial product administration.