Table 6.
Overview of adverse events in the overall trial and in early responders and early nonresponders (SCALE Obesity and Prediabetes trial)
| Liraglutide 3.0 mg | Placebo | |||||
|---|---|---|---|---|---|---|
| All randomized (N = 2,481) | ERs (N = 1,668) | ENRs (N = 491) | All randomized (N = 1,242) | ERs (N = 322) | ENRs (N = 735) | |
| Adverse events | 2,285 (92.1) | 1,559 (93.5) | 453 (92.3) | 1,043 (84.0) | 285 (88.5) | 651 (88.6) |
| Serious adverse events | 154 (6.2) | 106 (6.4) | 24 (4.9) | 62 (5.0) | 21 (6.5) | 33 (4.5) |
| Severe adverse events | 304 (12.3) | 190 (11.4) | 51 (10.4) | 113 (9.1) | 36 (11.2) | 66 (9.0) |
| Fatal | 1 (0.0) | 0 (0.0) | 1 (0.2) | 2 (0.2) | 0 (0.0) | 0 (0.0) |
| Leading to withdrawala | 244 (9.8) | 54 (3.2) | 20 (4.1) | 47 (3.8) | 4 (1.2) | 17 (2.3) |
AE data given as n (% of patients). Safety analysis set (for ERs and ENRs, all subjects with data at week 16).
aWithdrawal rates cover the entire trial period for “All randomized” and week 16 onwards for ERs and ENRs.
ERs, early responders (individuals who achieved ≥4% weight loss from baseline at 16 weeks); ENRs, early nonresponders (individuals who achieved <4% weight loss from baseline at 16 weeks).