Table 3.
Number of patients with AEs in the safety analysis set
| Exenatide QW plus dapagliflozin (n = 231) | Exenatide QW plus placebo (n = 230) | Dapagliflozin plus placebo (n = 233) | |
|---|---|---|---|
| Any AE | 165 (71.4) | 161 (70.0) | 156 (67.0) |
| Any SAE | 17 (7.4) | 18 (7.8) | 18 (7.7) |
| Any AE with outcome of death | 3 (1.3) | 1 (0.4) | 2 (0.9) |
| AEs leading to discontinuation of study treatment | 16 (6.9) | 14 (6.1) | 12 (5.2) |
| AEs leading to study withdrawal | 15 (6.5) | 10 (4.3) | 8 (3.4) |
| AEs occurring in ≥5% of patients | |||
| Upper respiratory tract infection | 15 (6.5) | 17 (7.4) | 22 (9.4) |
| Urinary tract infection | 19 (8.2) | 15 (6.5) | 16 (6.9) |
| Nausea | 13 (5.6) | 26 (11.3) | 10 (4.3) |
| Injection-site nodule | 20 (8.7) | 14 (6.1) | 13 (5.6) |
| Diarrhea | 13 (5.6) | 17 (7.4) | 11 (4.7) |
| Headache | 16 (6.9) | 12 (5.2) | 12 (5.2) |
| Nasopharyngitis | 15 (6.5) | 8 (3.5) | 12 (5.2) |
| Vomiting | 8 (3.5) | 12 (5.2) | 7 (3.0) |
| Genital infection AEs | |||
| Any genital infection | 12 (5.2) | 5 (2.2) | 18 (7.7) |
| AEs of special interest | |||
| Gastrointestinal AEs | 48 (20.8) | 55 (23.9) | 38 (16.3) |
| Volume depletion–related AEs | 3 (1.3) | 1 (0.4) | 5 (2.1) |
| Hematocrit >55% | 5 (2.2) | 2 (0.9) | 5 (2.1) |
| Pancreatitis-related AEs | 3 (1.3) | 1 (0.4) | 0 |
| Pancreatic carcinoma–related AEs | 1 (0.4) | 0 | 0 |
| Acute renal failure–related AEs | 0 | 2 (0.9) | 3 (1.3) |
| Adjudicated CV AEs | 4 (1.7) | 4 (1.7) | 4 (1.7) |
| Adjudicated hepatic AEs | 0 | 1 (0.4) | 1 (0.4) |
| Injection-site–related AEs | 32 (13.9) | 27 (11.7) | 18 (7.7) |
| Thyroid neoplasm–related AEs | 0 | 0 | 0 |
| Hypoglycemia | 16 (6.9) | 8 (3.5) | 9 (3.9) |
| Major | 0 | 0 | 0 |
| Minor | 4 (1.7) | 0 | 1 (0.4) |
| Other | 16 (6.9) | 8 (3.5) | 8 (3.4) |
| Anti-exenatide antibodies | |||
| Week 104 | 43 (29.5) | 34 (26.0) | — |
| Injection-site–related AEs by anti-exenatide antibody levels | |||
| Negative | 3 (1.3) | 3 (1.3) | — |
| High positive (≥625) | 18 (7.8) | 10 (4.3) | — |
| Low positive (<625) | 11 (4.8) | 14 (6.1) | — |
| Any positive | 29 (12.6) | 24 (10.4) | — |
Data are n (%). AEs occurring in ≥5% of patients are listed by Medical Dictionary for Regulatory Activities–preferred (MedDRA version 20.1) term; preferred terms for remaining AE categories are not listed. SAE, serious AE.