Table 3.
Summary of TEAEs in the overall population and by ethnicity – safety population
| Overall population | Japanese patients | Caucasian patients | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameter, n (%) | Lixisenatide QD (n = 39) | Lixisenatide BID (n = 41) | Placebo (n = 40) | Lixisenatide QD (n = 20) | Lixisenatide BID (n = 22) | Placebo (n = 21) | Lixisenatide QD (n = 19) | Lixisenatide BID (n = 19) | Placebo (n = 19) |
| Any TEAE | 35 (89.7) | 31 (75.6) | 29 (72.5) | 17 (85.0) | 17 (77.3) | 13 (61.9) | 18 (94.7) | 14 (73.7) | 16 (84.2) |
| Any serious TEAE | 0 | 1 (2.4) | 1 (2.5) | 0 | 0 | 0 | 0 | 1 (5.3) | 1 (5.3) |
| TEAE leading to treatment discontinuation | 0 | 2 (4.9) | 1 (2.5) | 0 | 1 (4.5) | 0 | 0 | 1 (5.3) | 1 (5.3) |
| Diarrhoea | 3 (7.7) | 9 (22.0) | 5 (12.5) | 1 (5.0) | 5 (22.7) | 1 (4.8) | 2 (10.5) | 4 (21.1) | 4 (21.1) |
| Nausea | 16 (41.0) | 8 (19.5) | 1 (2.5) | 10 (50.0) | 4 (18.2) | 0 | 6 (31.6) | 4 (21.1) | 1 (5.3) |
| Vomiting | 5 (12.8) | 6 (14.6) | 0 | 2 (10.0) | 4 (18.2) | 0 | 3 (15.8) | 2 (10.5) | 0 |
| Symptomatic hypoglycaemia (according to prespecified per-protocol definition) | 8 (20.5) | 9 (22.0) | 3 (7.5) | 4 (20.0) | 7 (31.8) | 3 (14.3) | 4 (21.1) | 2 (10.5) | 0 |
EU Clinical Trials Register Number: EUCTR2006-003138-13-DE. BID, twice daily; QD, once daily; TEAE, treatment-emergent adverse event.