Table 2.
Number (%) of patients with treatment-emergent adverse events (TEAEs) occurring in ≥5% (preferred term) in either group, symptomatic hypoglycaemia and injection site reactions
| TEAE, n (%) | Lixisenatide(n = 154) | Placebo(n = 157) |
|---|---|---|
| Any TEAE | 137 (89.0) | 110 (70.1) |
| Any serious TEAE | 10 (6.5) | 9 (5.7) |
| TEAE leading to death | 0 | 1 (0.6) |
| Discontinuation due to a TEAE | 14 (9.1) | 5 (3.2) |
| Gastrointestinal disorders (any) | 94 (61.0) | 23 (14.6) |
| Any TEAE occurring in ≥5% of patients in either group (Preferred term)* | ||
| Nausea | 61 (39.6) | 7 (4.5) |
| Vomiting | 28 (18.2) | 3 (1.9) |
| Nasopharyngitis | 21 (13.6) | 20 (12.7) |
| Headache | 16 (10.4) | 3 (1.9) |
| Dizziness | 13 (8.4) | 8 (5.1) |
| Abdominal discomfort | 11 (7.1) | 1 (0.6) |
| Dyspepsia | 11 (7.1) | 0 |
| Asthenia | 10 (6.5) | 12 (7.6) |
| Diarrhoea | 10 (6.5) | 4 (2.5) |
| Decreased appetite | 10 (6.5) | 0 |
| Constipation | 8 (5.2) | 4 (2.5) |
| Injection site reactions | 2 (1.3) | 2 (1.3) |
| Symptomatic hypoglycaemia (per protocol definition) | 66 (42.9) | 37 (23.6) |
| Blood glucose <60 mg/dL | 59 (38.3) | 32 (20.4) |
TEAE, treatment-emergent adverse events.
*
Excluding symptomatic hypoglycaemia.