Treatment-emergent adverse events*
. | Semaglutide 1.0 mg . | Exenatide ER 2.0 mg . | ||||
---|---|---|---|---|---|---|
Subjects experiencing ≥1 event, n (%) (n = 404) . | Events, n . | Event rate† . | Subjects experiencing ≥1 event, n (%) (n = 405) . | Events, n . | Event rate† . | |
AEs | 303 (75.0) | 1,551 | 374.7 | 309 (76.3) | 1,511 | 370.4 |
Serious AEs | 38 (9.4) | 52 | 12.6 | 24 (5.9) | 27 | 6.6 |
AEs leading to treatment discontinuation | 38 (9.4) | 48 | 11.6 | 29 (7.2) | 47 | 11.5 |
AEs occurring in ≥5% of subjects | ||||||
Nausea | 90 (22.3) | 159 | 38.4 | 48 (11.9) | 70 | 17.2 |
Diarrhea | 46 (11.4) | 86 | 20.8 | 34 (8.4) | 58 | 14.2 |
Lipase increased | 41 (10.1) | 51 | 12.3 | 49 (12.1) | 64 | 15.7 |
Nasopharyngitis | 39 (9.7) | 46 | 11.1 | 38 (9.4) | 51 | 12.5 |
Headache | 38 (9.4) | 81 | 19.6 | 39 (9.6) | 65 | 15.9 |
Decreased appetite | 32 (7.9) | 34 | 8.2 | 21 (5.2) | 24 | 5.9 |
Vomiting | 29 (7.2) | 37 | 8.9 | 25 (6.2) | 40 | 9.8 |
Dyspepsia | 27 (6.7) | 33 | 8.0 | 19 (4.7) | 23 | 5.6 |
Constipation | 26 (6.4) | 28 | 6.8 | 21 (5.2) | 26 | 6.4 |
Injection-site nodule | 0 (0.0) | 0 | 0 | 49 (12.1) | 55 | 13.5 |
. | Semaglutide 1.0 mg . | Exenatide ER 2.0 mg . | ||||
---|---|---|---|---|---|---|
Subjects experiencing ≥1 event, n (%) (n = 404) . | Events, n . | Event rate† . | Subjects experiencing ≥1 event, n (%) (n = 405) . | Events, n . | Event rate† . | |
AEs | 303 (75.0) | 1,551 | 374.7 | 309 (76.3) | 1,511 | 370.4 |
Serious AEs | 38 (9.4) | 52 | 12.6 | 24 (5.9) | 27 | 6.6 |
AEs leading to treatment discontinuation | 38 (9.4) | 48 | 11.6 | 29 (7.2) | 47 | 11.5 |
AEs occurring in ≥5% of subjects | ||||||
Nausea | 90 (22.3) | 159 | 38.4 | 48 (11.9) | 70 | 17.2 |
Diarrhea | 46 (11.4) | 86 | 20.8 | 34 (8.4) | 58 | 14.2 |
Lipase increased | 41 (10.1) | 51 | 12.3 | 49 (12.1) | 64 | 15.7 |
Nasopharyngitis | 39 (9.7) | 46 | 11.1 | 38 (9.4) | 51 | 12.5 |
Headache | 38 (9.4) | 81 | 19.6 | 39 (9.6) | 65 | 15.9 |
Decreased appetite | 32 (7.9) | 34 | 8.2 | 21 (5.2) | 24 | 5.9 |
Vomiting | 29 (7.2) | 37 | 8.9 | 25 (6.2) | 40 | 9.8 |
Dyspepsia | 27 (6.7) | 33 | 8.0 | 19 (4.7) | 23 | 5.6 |
Constipation | 26 (6.4) | 28 | 6.8 | 21 (5.2) | 26 | 6.4 |
Injection-site nodule | 0 (0.0) | 0 | 0 | 49 (12.1) | 55 | 13.5 |
*Treatment-emergent AE (by preferred term) include events with onset at or after the date of the first trial product dose and before or at the date of the last trial medication dose plus 5 weeks plus the 7-day visit window for the end-of-treatment follow-up visit (42 days).
†Event rate per 100 years of treatment exposure.