Table 3.
Adverse events during the study. Data are number (%) of patients from the safety population.
| Phase 1 only a (6-week EDI; n=15) | Phase 2 | All patients (n=124) | |||
|---|---|---|---|---|---|
| 4-week DI (n=13) | 6-week EDI (n=70) | 8-week EDI (n=26) | |||
| Any AE b | 12 (80.0) | 10 (76.9) | 49 (70.0) | 20 (76.9) | 91 (73.4) |
| Related to treatment | 7 (46.7) | 3 (23.1) | 32 (45.7) | 12 (46.2) | 54 (43.5) |
| Severe/moderate/mild | 5 (33.3)/8 (53.3)/9 (60.0) | 3 (23.1)/3 (23.1)/9 (69.2) | 6 (8.6)/23 (32.9)/43 (61.4) | 3 (11.5)/8 (30.8)/17 (65.4) | 17 (13.7)/42 (33.9)/78 (62.9) |
| Leading to withdrawal c | 7 (46.7) | 0 | 1 (1.4) | 0 | 8 (6.5) |
| Any serious AE d | 3 (20.0) | 2 (15.4) | 4 (5.7) | 2 (7.7) | 11 (8.9) |
| Related to treatment | 1 (6.7) | 0 | 0 | 0 | 1 (0.8) |
| AEs in >10% of patients | |||||
| Dizziness | 3 (20.0) | 0 | 1 (1.4) | 0 | 4 (3.2) |
| Flatulence | 2 (13.3) | 0 | 2 (2.9) | 1 (3.8) | 5 (4.0) |
| Constipation | 2 (13.3) | 0 | 0 | 0 | 2 (1.6) |
| Cholelithiasis | 1 (6.7) | 2 (15.4) | 7 (10.0) | 4 (15.4) | 14 (11.3) |
| Diarrhoea | 1 (6.7) | 0 | 11 (15.7) | 1 (3.8) | 13 (10.5) |
| Dyslipidaemia | 1 (6.7) | 0 | 6 (8.6) | 3 (11.5) | 10 (8.1) |
| Headache | 1 (6.7) | 2 (15.4) | 2 (2.9) | 2 (7.7) | 7 (5.6) |
| Nasopharyngitis | 0 | 2 (15.4) | 3 (4.3) | 0 | 5 (4.0) |
| Gallbladder polyp | 0 | 2 (15.4) | 0 | 1 (3.8) | 3 (2.4) |
| Osteoarthritis | 0 | 2 (15.4) | 0 | 0 | 2 (1.6) |
| Abdominal discomfort | 0 | 1 | 1 (1.4) | 3 (11.5) | 4 (3.2) |
AE, adverse event; DI, dosing interval; EDI, extended dosing interval.
a
Patients from phase 1 not entering phase 2.
b
Any AE refers to treatment-emergent AEs; that is, all AEs that occurred during the study.
c
None of the AEs leading to withdrawal occurred in more than one patient; four patients had events leading to withdrawal that were considered to be related to treatment.
d
No individual serious AEs occurred in more than one patient.