Table 2.
On‐treatment adverse events up to week 57 in PIONEER 9 and PIONEER 10 by subgroup
| PIONEER 9 | PIONEER 10 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Oral semaglutide 3 mg | Oral semaglutide 7 mg | Oral semaglutide 14 mg | Liraglutide 0.9 mg | Placebo | Oral semaglutide 3 mg | Oral semaglutide 7 mg | Oral semaglutide 14 mg | Dulaglutide 0.75 mg | |
| By baseline HbA1c, % | |||||||||
| Patients, N | |||||||||
| ≤8.0 | 31 | 25 | 27 | 22 | 23 | 62 | 59 | 58 | 27 |
| >8.0–≤9.0 | 10 | 12 | 15 | 16 | 15 | 41 | 48 | 35 | 20 |
| >9.0 | 8 | 12 | 6 | 10 | 11 | 28 | 25 | 37 | 18 |
| Any AEs, n (%) | |||||||||
| ≤8.0 | 23 (74.2) | 21 (84.0) | 19 (70.4) | 17 (77.3) | 16 (69.6) | 44 (71.0) | 53 (89.8) | 51 (87.9) | 23 (85.2) |
| >8.0–≤9.0 | 9 (90.0) | 8 (66.7) | 10 (66.7) | 11 (68.8) | 14 (93.3) | 35 (85.4) | 34 (70.8) | 30 (85.7) | 15 (75.0) |
| >9.0 | 5 (62.5) | 8 (66.7) | 5 (83.3) | 4 (40.0) | 9 (81.8) | 22 (78.6) | 19 (76.0) | 30 (81.1) | 15 (83.3) |
| SAEs, n (%) | |||||||||
| ≤8.0 | 1 (3.2) | 1 (4.0) | 0 | 0 | 0 | 3 (4.8) | 2 (3.4) | 5 (8.6) | 1 (3.7) |
| >8.0–≤9.0 | 1 (10.0) | 1 (8.3) | 0 | 0 | 1 (6.7) | 4 (9.8) | 2 (4.2) | 1 (2.9) | 0 |
| >9.0 | 0 | 1 (8.3) | 0 | 0 | 2 (18.2) | 2 (7.1) | 0 | 1 (2.7) | 0 |
| GI AEs, n (%) | |||||||||
| ≤8.0 | 9 (29.0) | 7 (28.0) | 8 (29.6) | 10 (45.5) | 4 (17.4) | 17 (27.4) | 27 (45.8) | 31 (53.4) | 12 (44.4) |
| >8.0–≤9.0 | 5 (50.0) | 4 (33.3) | 5 (33.3) | 4 (25.0) | 2 (13.3) | 14 (34.1) | 15 (31.3) | 19 (54.3) | 8 (40.0) |
| >9.0 | 3 (37.5) | 7 (58.3) | 3 (50.0) | 4 (40.0) | 4 (36.4) | 9 (32.1) | 9 (36.0) | 20 (54.1) | 6 (33.3) |
| By baseline BMI, kg/m2 | |||||||||
| Patients, N | |||||||||
| <25 | 18 | 19 | 28 | 19 | 24 | 65 | 54 | 55 | 33 |
| ≥25–<30 | 25 | 22 | 15 | 18 | 20 | 49 | 53 | 55 | 23 |
| ≥30 | 6 | 8 | 5 | 11 | 5 | 17 | 25 | 20 | 9 |
| Any AEs, n (%) | |||||||||
| <25 | 15 (83.3) | 14 (73.7) | 20 (71.4) | 11 (57.9) | 20 (83.3) | 50 (76.9) | 44 (81.5) | 51 (92.7) | 28 (84.8) |
| ≥25–<30 | 16 (64.0) | 16 (72.7) | 11 (73.3) | 12 (66.7) | 15 (75.0) | 38 (77.6) | 41 (77.4) | 45 (81.8) | 18 (78.3) |
| ≥30 | 6 (100) | 7 (87.5) | 3 (60.0) | 9 (81.8) | 4 (80.0) | 13 (76.5) | 21 (84.0) | 15 (75.0) | 7 (77.8) |
| SAEs, n (%) | |||||||||
| <25 | 0 | 2 (10.5) | 0 | 0 | 3 (12.5) | 4 (6.2) | 2 (3.7) | 2 (3.6) | 1 (3.0) |
| ≥25–<30 | 0 | 1 (4.5) | 0 | 0 | 0 | 5 (10.2) | 2 (3.8) | 5 (9.1) | 0 |
| ≥30 | 2 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| GI AEs, n (%) | |||||||||
| <25 | 6 (33.3) | 7 (36.8) | 12 (42.9) | 8 (42.1) | 5 (20.8) | 19 (29.2) | 25 (46.3) | 35 (63.6) | 12 (36.4) |
| ≥25–<30 | 7 (28.0) | 8 (36.4) | 3 (20.0) | 4 (22.2) | 4 (20.0) | 17 (34.7) | 20 (37.7) | 25 (45.5) | 9 (39.1) |
| ≥30 | 4 (66.7) | 3 (37.5) | 1 (20.0) | 6 (54.5) | 1 (20.0) | 4 (23.5) | 6 (24.0) | 10 (50.0) | 5 (55.6) |
| By background medication † | |||||||||
| Patients, N | |||||||||
| SU | – | – | – | – | – | 42 | 42 | 42 | 21 |
| Glinide | – | – | – | – | – | 22 | 22 | 22 | 11 |
| TZD | – | – | – | – | – | 23 | 23 | 22 | 11 |
| α‐GI | – | – | – | – | – | 22 | 22 | 22 | 11 |
| SGLT2i | – | – | – | – | – | 22 | 23 | 22 | 11 |
| Any AEs, n (%) | |||||||||
| SU | – | – | – | – | – | 36 (85.7) | 34 (81.0) | 38 (90.5) | 19 (90.5) |
| Glinide | – | – | – | – | – | 18 (81.8) | 19 (86.4) | 21 (95.5) | 10 (90.9) |
| TZD | – | – | – | – | – | 19 (82.6) | 16 (69.6) | 15 (68.2) | 8 (72.7) |
| α‐GI | – | – | – | – | – | 11 (50.0) | 18 (81.8) | 17 (77.3) | 8 (72.7) |
| SGLT2i | – | – | – | – | – | 17 (77.3) | 19 (82.6) | 20 (90.9) | 8 (72.7) |
| SAEs, n (%) | |||||||||
| SU | – | – | – | – | – | 3 (7.1) | 2 (4.8) | 2 (4.8) | 0 |
| Glinide | – | – | – | – | – | 1 (4.5) | 1 (4.5) | 1 (4.5) | 0 |
| TZD | – | – | – | – | – | 3 (13.0) | 0 | 1 (4.5) | 0 |
| α‐GI | – | – | – | – | – | 1 (4.5) | 1 (4.5) | 2 (9.1) | 1 (9.1) |
| SGLT2i | – | – | – | – | – | 1 (4.5) | 0 | 1 (4.5) | 0 |
| GI AEs, n (%) | |||||||||
| SU | – | – | – | – | – | 16 (38.1) | 20 (47.6) | 26 (61.9) | 11 (52.4) |
| Glinide | – | – | – | – | – | 4 (18.2) | 7 (31.8) | 13 (59.1) | 8 (72.7) |
| TZD | – | – | – | – | – | 13 (56.5) | 7 (30.4) | 9 (40.9) | 2 (18.2) |
| α‐GI | – | – | – | – | – | 2 (9.1) | 8 (36.4) | 9 (40.9) | 1 (9.1) |
| SGLT2i | – | – | – | – | – | 5 (22.7) | 9 (39.1) | 13 (59.1) | 4 (36.4) |
The on‐treatment observation period started at the date of first dose of trial product, included the period after initiation of rescue medication (if any), and excluded the period after trial product discontinuation (if applicable). α‐GI, alpha‐glucosidase inhibitor; AE, adverse event; BMI, body mass index; GI, gastrointestinal; HbA1c, glycated hemoglobin; n, number of patients with at least one event; N, number of patients contributing to the analysis; SAE, serious adverse event; SGLT2i, sodium‐glucose cotransporter‐2 inhibitor; SU, sulfonylurea; TZD, thiazolidinedione.
†
Only data from PIONEER 10 were analyzed by background medication.