Table 1.
Summary of treatment-emergent adverse events and discontinuations
| Patients with treatment-emergent AEs | Exenatide BID (N = 3261) | Pooled comparator (N = 2333) | Risk difference |
|---|---|---|---|
|
|
|||
| n (%) | n (%) | (95% CI)b | |
| With one or more AEs | 2653 (81.4) | 1613 (69.1) | 12.3 (9.9, 14.5) |
| With study drug-related AEsa | 1569 (48.1) | 372 (15.9) | 32.2 (29.9, 34.4) |
| With GI-related AEs | 1677 (51.4) | 495 (21.2) | 30.2 (27.8, 32.6) |
| With serious AEs | 119 (3.6) | 90 (3.9) | −0.3 (−1.2, 0.8) |
| With serious drug-related AEsa | 14 (0.4) | 5 (0.2) | 0.2 (−0.1, 0.5) |
| Deaths | 2 (<0.1) | 3 (<0.1) | 0 (−0.2, 0.1) |
| Discontinued due to AEs | 255 (7.8) | 43 (1.8) | 6.0 (4.9, 7.0) |
| Discontinued due to drug-related AEsa | 207 (6.3) | 18 (0.8) | 5.5 (4.7, 6.5) |
| Discontinued due to serious AEs | 25 (0.8) | 17 (0.7) | 0.1 (−0.4, 0.5) |
| Discontinued due to serious drug-related AEsa | 5 (0.2) | 2 (0.1) | 0.1 (−0.1, 0.2) |
| Discontinued due to GI-related AEs | 173 (5.3) | 7 (0.3) | 5.0 (4.2, 5.8) |
Notes:
a
Determined by the investigator to be possibly, probably, or definitely drug-related;
b
RD = Exenatide IR (%) minus pooled comparator IR (%).
Abbreviations: AEs, adverse events; BID, twice daily; CI, confidence interval; GI, gastrointestinal.