Safety data (on-drug)
| . | Liraglutide 3.0 mg . | Placebo . | ||||
|---|---|---|---|---|---|---|
| n (%) . | E . | R . | n (%) . | E . | R . | |
| Number of individuals | 195 | — | — | 197 | — | — |
| Total AEs | 180 (92.3) | 1,139 | 578.3 | 175 (88.8) | 1,053 | 531.2 |
| Serious AEs | 16 (8.2) | 23 | 11.7 | 19 (9.6) | 25 | 12.6 |
| Fatal AEs | 0 (0.0) | 0 | 0.0 | 0 (0.0) | 0 | 0.0 |
| Events leading to treatment discontinuation | 15 (7.7) | 17 | 8.6 | 6 (3.0) | 6 | 3.0 |
| GI AEs | 121 (62.1) | 408 | 207.1 | 92 (46.7) | 202 | 101.9 |
| Nausea | 58 (29.7) | 105 | 53.3 | 23 (11.7) | 27 | 13.6 |
| Constipation | 28 (14.4) | 36 | 18.3 | 17 (8.6) | 21 | 10.6 |
| Diarrhea | 45 (23.1) | 77 | 39.1 | 30 (15.2) | 54 | 27.2 |
| Vomiting | 32 (16.4) | 53 | 26.9 | 12 (6.1) | 13 | 6.6 |
| Abdominal discomfort | 11 (5.6) | 17 | 8.6 | 8 (4.1) | 11 | 5.5 |
| Hypoglycemic episodes | 140 (71.8) | 1,462 | 742.3 | 140 (71.1) | 1,859 | 937.9 |
| ADA classified | ||||||
| Severe | 3 (1.5) | 3 | 1.5 | 2 (1.0) | 2 | 1.0 |
| Asymptomatic | 116 (59.5) | 742 | 376.7 | 116 (58.9) | 988 | 498.4 |
| Documented symptomatic | 92 (47.2) | 662 | 336.1 | 102 (51.8) | 816 | 411.7 |
| Pseudohypoglycemia | 17 (8.7) | 42 | 21.3 | 14 (7.1) | 31 | 15.6 |
| Probable symptomatic | 8 (4.1) | 10 | 5.1 | 18 (9.1) | 22 | 11.1 |
| Unclassifiable | 2 (1.0) | 3 | 1.5 | 0 (0.0) | 0 | 0 |
| . | Liraglutide 3.0 mg . | Placebo . | ||||
|---|---|---|---|---|---|---|
| n (%) . | E . | R . | n (%) . | E . | R . | |
| Number of individuals | 195 | — | — | 197 | — | — |
| Total AEs | 180 (92.3) | 1,139 | 578.3 | 175 (88.8) | 1,053 | 531.2 |
| Serious AEs | 16 (8.2) | 23 | 11.7 | 19 (9.6) | 25 | 12.6 |
| Fatal AEs | 0 (0.0) | 0 | 0.0 | 0 (0.0) | 0 | 0.0 |
| Events leading to treatment discontinuation | 15 (7.7) | 17 | 8.6 | 6 (3.0) | 6 | 3.0 |
| GI AEs | 121 (62.1) | 408 | 207.1 | 92 (46.7) | 202 | 101.9 |
| Nausea | 58 (29.7) | 105 | 53.3 | 23 (11.7) | 27 | 13.6 |
| Constipation | 28 (14.4) | 36 | 18.3 | 17 (8.6) | 21 | 10.6 |
| Diarrhea | 45 (23.1) | 77 | 39.1 | 30 (15.2) | 54 | 27.2 |
| Vomiting | 32 (16.4) | 53 | 26.9 | 12 (6.1) | 13 | 6.6 |
| Abdominal discomfort | 11 (5.6) | 17 | 8.6 | 8 (4.1) | 11 | 5.5 |
| Hypoglycemic episodes | 140 (71.8) | 1,462 | 742.3 | 140 (71.1) | 1,859 | 937.9 |
| ADA classified | ||||||
| Severe | 3 (1.5) | 3 | 1.5 | 2 (1.0) | 2 | 1.0 |
| Asymptomatic | 116 (59.5) | 742 | 376.7 | 116 (58.9) | 988 | 498.4 |
| Documented symptomatic | 92 (47.2) | 662 | 336.1 | 102 (51.8) | 816 | 411.7 |
| Pseudohypoglycemia | 17 (8.7) | 42 | 21.3 | 14 (7.1) | 31 | 15.6 |
| Probable symptomatic | 8 (4.1) | 10 | 5.1 | 18 (9.1) | 22 | 11.1 |
| Unclassifiable | 2 (1.0) | 3 | 1.5 | 0 (0.0) | 0 | 0 |
Safety analysis set. Hypoglycemic episodes were classified using ADA criteria and recorded in individual diaries. Data are from individuals on-drug.
E, number of events; GI, gastrointestinal; n, number of individuals experiencing at least one event; %, percentage of individuals experiencing at least one event; R, event rate per 100 patient-years of exposure.