Analysis 15.5.
Comparison 15 Lixisenatide versus placebo, Outcome 5 Adverse events.
Adverse events
| Study | Description | LIXI 5 μg QD | LIXI 10 μg QD | LIXI 20 μg QD | LIXI 30 μg QD | LIXI 5 μg BID | LIXI 10 μg BID | LIXI 20 μg BID | LIXI 30 μg BID | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Lixi ‐ Ratner 2010 | Withdrawals due to adverse events | 1 (1.8%) | 2 (3.8%) | 3 (5.5%) | 6 (11.1%) | 0 | 2 (3.6%) | 8 (14.8%) | 5 (9.3%) | 2 (1.8%) |
| Lixi ‐ Ratner 2010 | Any treatment‐emergent adverse events | 31 (56.4%) | 26 (50.0%) | 37 (67.3%) | 42 (77.8%) | 30 (56.6%) | 32 (57.1%) | 38 (70.4%) | 40 (74.1%) | 65 (59.6%) |
| Lixi ‐ Ratner 2010 | Nausea | 4 (7.3%) | 6 (11.5%) | 14 (25.5%) | 19 (35.2%) | 4 (7.5%) | 8 (14.3%) | 12 (22.2%) | 18 (33.3%) | 5 (4.6%) |
| Lixi ‐ Ratner 2010 | Vomiting | 2 (3.6%) | 3 (5.8%) | 3 (5.5%) | 10 (18.5%) | 3 (5.7%) | 4 (7.1%) | 5 (9.3%) | 2 (3.7%) | 1 (0.9%) |
| Lixi ‐ Ratner 2010 | Diarrhoea | 3 (5.5%) | 4 (7.7%) | 5 (9.1%) | 4 (7.4%) | 3 (5.7%) | 4 (7.1%) | 6 (11.1%) | 14 (25.9%) | 8 (7.3%) |
| Lixi ‐ Ratner 2010 | Headache | 7 (12.7%) | 3 (5.8%) | 7 (12.7%) | 7 (13.0%) | 7 (13.2%) | 5 (8.9%) | 6 (11.1%) | 4 (7.4%) | 11 (10.1%) |
| Lixi ‐ Ratner 2010 | Dizziness | 1 (1.8%) | 4 (7.7%) | 4 (7.3%) | 6 (11.1%) | 3 (5.7%) | 5 (8.9%) | 2 (3.7%) | 5 (9.3%) | 7 (6.4%) |
| Lixi ‐ Ratner 2010 | Any serious treatment‐emergent adverse events | 0 | 1 (1.9%) | 1 (1.8%) | 3 (5.6%) | 0 | 1 (1.8%) | 2 (3.7%) | 0 | 3 (2.8%) |
| Lixi ‐ Ratner 2010 | Pancreatitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lixi ‐ Ratner 2010 | Severe hypoglycaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |