Table 2.
Summary of TEAEs during Ramadan
| Event | Liraglutide 1.8 mg | Sulphonylurea | ||||||
|---|---|---|---|---|---|---|---|---|
| N | % | E | R | N | % | E | R | |
| All AEs | 36 | 23.7 | 64 | 5258 | 34 | 20.9 | 43 | 3349 |
| Severe | 3 | 2.0 | 5 | 411 | 1 | 0.6 | 1 | 78 |
| Moderate | 10 | 6.6 | 12 | 986 | 9 | 5.5 | 10 | 779 |
| Mild | 27 | 17.8 | 47 | 3861 | 25 | 15.3 | 32 | 2492 |
| Serious | 2 | 1.3 | 2 | 164 | 0 | 0 | 0 | 0 |
| Fatal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Possibly or probably related to investigational medical product | 13 | 8.6 | 24 | 1972 | 0 | 0 | 0 | 0 |
| Gastrointestinal | 13 | 8.6 | 20 | 1643 | 0 | 0 | 0 | 0 |
| Leading to withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Frequently reported AEs | ||||||||
| Gastrointestinal AEs | 16 | 10.5 | 28 | 2300 | 6 | 3.7 | 9 | 701 |
| Vomiting | 8 | 5.3 | 9 | 739 | 1 | 0.6 | 1 | 78 |
| Nausea | 7 | 4.6 | 7 | 575 | 0 | 0 | 0 | 0 |
| Diarrhoea | 4 | 2.6 | 4 | 329 | 3 | 1.8 | 3 | 234 |
| Constipation | 1 | 0.7 | 1 | 82 | 0 | 0 | 0 | 0 |
| Infection and infestations | 10 | 6.6 | 10 | 822 | 7 | 4.3 | 7 | 545 |
| Infections, pathogen unspecified | 8 | 5.3 | 8 | 657 | 6 | 3.7 | 6 | 467 |
AEs, adverse events; E, number of events; N, number of subjects; R, event rate/1000 patient‐years of exposure; TEAE, treatment‐emergent adverse event.