TABLE 2.
Most common TEAEs occurring in the phase 2a and phase 2b trials
| TEAEs ≥5% in any treatment group in either study, n (%) | Phase 2a | Phase 2b | |||||
|---|---|---|---|---|---|---|---|
| Placebo | Relamorelin | Placebo | Relamorelin | ||||
| b.d. (n = 69) | 10 µg q.d. pm (n = 67) | 10 µg b.d. (n = 68) | b.d. (n = 104) | 10 µg b.d. (n = 98) | 30 µg b.d. (n = 109) | 100 µg b.d. (n = 82) | |
| Constipation | 4 (5.8) | 1 (1.5) | 1 (1.5) | 3 (2.9) | 0 | 3 (2.8) | 0 |
| Diarrhoea | 2 (2.9) | 3 (4.5) | 1 (1.5) | 0 | 4 (4.1) | 7 (6.4) | 6 (7.3) |
| Dizziness | 4 (5.8) | 1 (1.5) | 1 (1.5) | 1 (1.0) | 0 | 1 (0.9) | 5 (6.1) |
| Headache | 2 (2.9) | 2 (3.0) | 5 (7.4) | 3 (2.9) | 4 (4.1) | 6 (5.5) | 2 (2.4) |
| Urinary tract infection | 4 (5.8) | 2 (3.0) | 2 (2.9) | 7 (6.7) | 7 (7.1) | 8 (7.3) | 7 (8.5) |
| TEAEs related to glycaemic control | |||||||
| Hyperglycaemia | 1 (1.4) | 2 (3.0) | 0 | 2 (1.9) | 5 (5.1) | 10 (9.2) | 10 (12.2) |
| Increased blood glucose | 1 (1.4) | 0 | 1 (1.5) | 1 (1.0) | 3 (3.1) | 4 (3.7) | 6 (7.3) |
| Diabetes mellitus | 2 (2.9) | 1 (1.5) | 4 (5.9) | 0 | 2 (2.0) | 1 (0.9) | 3 (3.7) |
Abbreviations: b.d., twice daily; q.d. pm, once daily in the evening; TEAE, treatment‐emergent adverse event.