Table 2.
Summary of treatment‐emergent adverse events (safety analysis set)
| Liraglutide + insulin (n = 127) | Liraglutide placebo + insulin (n = 130) | |||||
|---|---|---|---|---|---|---|
| n (%) | No. events | Event rate per 100 PYE | n (%) | No. events | Event rate per 100 PYE | |
| All AEs | 109 (85.8) | 379 | 449 | 106 (81.5) | 302 | 350 |
| Serious AEs | 6 (4.7) | 7 | 8 | 4 (3.1) | 4 | 5 |
| Severity | ||||||
| Severe | 4 (3.1) | 4 | 5 | 1 (0.8) | 1 | 1 |
| Moderate | 5 (3.9) | 7 | 8 | 10 (7.7) | 12 | 14 |
| Mild | 109 (85.8) | 368 | 436 | 104 (80.0) | 289 | 335 |
| Treatment‐emergent adverse events occurring with a frequency ≥5% | ||||||
| Nasopharyngitis | 55 (43.3) | 74 | 88 | 40 (30.8) | 60 | 70 |
| Gastroenteritis | 4 (3.1) | 7 | 8 | 7 (5.4) | 7 | 8 |
| GI disorders | ||||||
| Nausea | 14 (11.0) | 16 | 19 | 7 (5.4) | 9 | 10 |
| Diarrhea | 15 (11.8) | 17 | 20 | 4 (3.1) | 4 | 5 |
| Constipation | 15 (11.8) | 16 | 19 | 2 (1.5) | 2 | 2 |
| Dyspepsia | 7 (5.5) | 9 | 11 | 0 (0) | 0 | 0 |
| Diabetic retinopathy | 9 (7.1) | 9 | 11 | 13 (10.0) | 16 | 19 |
| Headache | 8 (6.3) | 10 | 12 | 6 (4.6) | 6 | 7 |
| Hypertension | 8 (6.3) | 8 | 9 | 6 (4.6) | 6 | 7 |
| Back pain | 6 (4.7) | 6 | 7 | 7 (5.4) | 7 | 8 |
AE, adverse event; GI, gastrointestinal; PYE, patient years of exposure.