Table 4.
Adverse events leading to premature treatment discontinuation in the safety analysis set
| SUSTAIN 2 | SUSTAIN 3 | SUSTAIN 4 | SUSTAIN 10 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MET | MET | MET + SU | MET | MET + SU | MET | MET + SU | |||||||||||
| Sema 0.5 mg |
Sema 1.0 mg |
Sita | Sema 1.0 mg |
Exe ER |
Sema 1.0 mg |
Exe ER |
Sema 0.5 mg |
Sema 1.0 mg |
IGlar | Sema 0.5 mg |
Sema 1.0 mg |
IGlar | Sema 1.0 mg |
Lira 1.2 mg |
Sema 1.0 mg |
Lira 1.2 mg |
|
| N | 382 | 388 | 382 | 213 | 188 | 167 | 196 | 176 | 175 | 172 | 186 | 185 | 187 | 106 | 104 | 104 | 99 |
| Subjects with AEs leading to premature treatment discontinuationa, n (%) |
29 (7.6) |
35 (9.0) |
12 (3.1) |
21 (9.9) |
16 (8.5) |
16 (9.6) |
9 (4.6) |
15 (8.5) |
14 (8.0) |
3 (1.7) |
5 (2.7) |
13 (7.0) |
1 (0.5) |
15 (14.2) |
7 (6.7) |
12 (11.5) |
6 (6.1) |
| Serious AEs, n (%) |
4 (1.0) |
2 (0.5) |
4 (1.0) |
3 (1.4) |
0 (0.0) |
3 (1.8) |
0 (0.0) |
1 (0.6) |
1 (0.6) |
1 (0.6) |
2 (1.1) |
0 (0.0) |
0 (0.0) |
2 (1.9) |
2 (1.9) |
0 (0.0) |
1 (1.0) |
Data are presented as number of patients with an AE or serious AE, as a percentage of the safety analysis set
AE adverse event, Exe ER exenatide extended release, IGlar insulin glargine, Lira liraglutide, MET metformin, n number of subjects with events, N number of subjects in the safety analysis set, Sema semaglutide, Sita sitagliptin, SU sulphonylurea
aReflects subjects/events with ‘Drug withdrawn’ as action taken with trial drug