Table 2. Summary of safety data, gastrointestinal disorders with an incidence of ⩾5% in any group and all psychiatric disorders in year 1.
| Placebo n=98 |
Liraglutide |
Orlistat n=95 | ||||
|---|---|---|---|---|---|---|
| 1.2 mg n=95 | 1.8 mg n=90 | 2.4 mg n=93 | 3.0 mg n=93 | |||
| N (%) E | N (%) E | N (%) E | N (%) E | N (%) E | N (%) E | |
| Summary of safety data | ||||||
| Overall withdrawal ratea | 24 (25) | 17 (18) | 20 (22) | 27 (29) | 18 (19) | 28 (30) |
| Participants with AEs | 87 (88.8) 374 | 88 (92.6) 362 | 84 (93.3) 430 | 88 (94.6) 485 | 89 (95.7) 492 | 89 (93.7) 372 |
| Participants with any SAE | 3 (3.1) 3 | 2 (2.1) 2 | 7 (7.8) 7 | 4 (4.3) 5 | 7 (7.5) 10 | 2 (2.1) 2 |
| Withdrawals due to AEs | 3 (3.1) 7 | 5 (5.3) 12 | 6 (6.7) 10 | 12 (12.9) 20 | 7 (7.5) 12 | 3 (3.2) 3 |
| Gastrointestinal disorders | 37 (37.8) 62 | 55 (57.9) 101 | 58 (64.4) 121 | 66 (71.0) 157 | 72 (77.4) 167 | 60 (63.2) 110 |
| Abdominal pain | 4 (4.1) 4 | 2 (2.1) 2 | 3 (3.3) 3 | 1 (1.1) 1 | 5 (5.4) 5 | 4 (4.2) 5 |
| Abdominal pain upper | 1 (1.0) 1 | 5 (5.3) 6 | 2 (2.2) 3 | 5 (5.4) 5 | 5 (5.4) 7 | 7 (7.4) 8 |
| Constipation | 12 (12.2) 14 | 15 (15.8) 17 | 11 (12.2) 12 | 21 (22.6) 24 | 17 (18.3) 18 | 7 (7.4) 8 |
| Diarrhea | 10 (10.2) 11 | 8 (8.4) 13 | 9 (10.0) 12 | 12 (12.9) 13 | 14 (15.1) 15 | 28 (29.5) 40 |
| Dyspepsia | 3 (3.1) 3 | 6 (6.3) 7 | 7 (7.8) 7 | 9 (9.7) 13 | 8 (8.6) 8 | 3 (3.2) 4 |
| Flatulence | 1 (1.0) 1 | — | 4 (4.4) 4 | 4 (4.3) 4 | 3 (3.2) 3 | 10 (10.5) 10 |
| Nausea | 7 (7.1) 8 | 23 (24.2) 27 | 29 (32.2) 33 | 35 (37.6) 48 | 45 (48.4) 68 | 7 (7.4) 7 |
| Steatorrhea | — | — | — | — | — | 5 (5.3) 5 |
| Toothache | 1 (1.0) 1 | 1 (1.1) 1 | 5 (5.6) 7 | 1 (1.1) 1 | — | 1 (1.1) 1 |
| Vomiting | 2 (2.0) 2 | 5 (5.3) 6 | 9 (10.0) 18 | 14 (15.1) 17 | 12 (12.9) 16 | 2 (2.1) 4 |
| Psychiatric disorders | 5 (5.1) 5 | 3 (3.2) 3 | 4 (4.4) 4 | 11 (11.8) 14 | 12 (12.9) 14 | 5 (5.3) 8 |
| Acute stress disorder | — | — | — | 1 (1.1) 1 | — | — |
| Affect lability | — | — | — | — | — | 1 (1.1) 1 |
| Alcohol abuse | — | — | — | — | — | 1 (1.1) 1 |
| Anxiety | 1 (1.0) 1 | — | — | 2 (2.2) 2 | 2 (2.2) 2 | — |
| Burnout syndrome | — | — | — | — | 1 (1.1) 1 | — |
| Depressed mood | — | 1 (1.1) 1 | — | 3 (3.2) 3 | 1 (1.1) 1 | — |
| Depression | — | — | 2 (2.2) 2 | 2 (2.2) 2 | 1 (1.1) 1 | 2 (2.1) 3 |
| Eating disorder | — | — | — | 1 (1.1) 1 | — | — |
| Food aversion | — | 1 (1.1) 1 | — | — | — | — |
| Insomnia | 2 (2.0) 2 | — | — | 2 (2.2) 2 | 5 (5.4) 6 | 2 (2.1) 3 |
| Mood altered | — | — | — | 1 (1.1) 1 | 1 (1.1) 1 | — |
| Nervousness | — | — | — | 2 (2.2) 2 | — | — |
| Restlessness | — | — | 1 (1.1) 1 | — | — | — |
| Stress | 2 (2.0) 2 | 1 (1.1) 1 | 1 (1.1) 1 | — | 2 (2.2) 2 | — |
Abbreviations: AE, adverse event; E, number of adverse event; N (%), number and proportion of participants with an adverse event; SAE, serious adverse event.
a
Does not include individuals who chose not to enroll in the extension period.