Table 4 Adverse event summary: short-term period and long-term extension
SAXA 2.5 mg q.A.M. (n = 74) | SAXA 5 mg q.A.M. (n = 74) | SAXA 2.5/5 mg q.A.M. (n = 71) | SAXA 5 mg q.P.M. (n = 72) | All SAXA (n = 291) | Control (n = 74) | |
|---|---|---|---|---|---|---|
Adverse events n (%)* | ||||||
≥1 AE | 49 (66.2) | 54 (73.0) | 53 (74.6) | 51 (70.8) | 207 (71.1) | 41 (55.4) |
≥1 related AE | 17 (23.0) | 17 (23.0) | 14 (19.7) | 10 (13.9) | 58 (19.9) | 11 (14.9) |
Deaths | 0 | 0 | 2 (2.8) | 0 | 2 (0.7) | 0 |
≥1 SAE | 7 (9.5) | 8 (10.8) | 7 (9.9) | 4 (5.6) | 26 (8.9) | 5 (6.8) |
≥1 related SAE | 1 (1.4) | 0 | 0 | 0 | 1 (0.3) | 1 (1.4) |
Discontinuation due to AE | 4 (5.4) | 2 (2.7) | 5 (7.0) | 1 (1.4) | 12 (4.1) | 3 (4.1) |
Discontinuation due to SAEs | 1 (1.4) | 0 | 2 (2.8) | 0 | 3 (1.0) | 2 (2.7) |
Adverse events (≥5% All SAXA)† | ||||||
URTI | 11 (14.9) | 10 (13.5) | 11 (15.5) | 11 (15.3) | 43 (14.8) | 7 (9.5) |
Nasopharyngitis | 3 (4.1) | 4 (5.4) | 3 (4.2) | 5 (6.9) | 15 (5.2) | 3 (4.1) |
Diarrhea | 7 (9.5) | 4 (5.4) | 1 (1.4) | 4 (5.6) | 16 (5.5) | 1 (1.4) |
Pain in extremity | 2 (2.7) | 3 (4.1) | 5 (7.0) | 5 (6.9) | 15 (5.2) | 1 (1.4) |
Reported hypoglycemia‡ | 3 (4.1) | 6 (8.1) | 6 (8.5) | 6 (8.3) | 21 (7.2) | 3 (4.1) |
Confirmed hypoglycemia** | 0 | 1 (1.4) | 0 | 1 (1.4) | 2 (0.7) | 1 (1.4) |
Exposure, weeks, mean (SD)*** | 54.6 (27.6) | 62.2 (24.3) | 56.8 (27.2) | 59.8 (25.0) | − | 58.8 (25.8) |