Table 3. Adverse Events and Serious Adverse Eventsa.
Adverse Event or Reaction | No. (%) of Participants | P Valueb | |
---|---|---|---|
Liraglutide Treatment Group (n = 52) |
Placebo Treatment Group (n = 51) |
||
Gastrointestinal tract | |||
Nausea | 31/50 (62.0) | 16/50 (32.0) | .008 |
Diarrhea | 10/50 (20.0) | 7/50 (14.0) | .42 |
Constipation | 18/50 (36.0) | 11/50 (22.0) | .16 |
Vomiting | 15/49 (30.6) | 9/50 (18.0) | .09 |
Dyspepsia | 17/50 (34.0) | 11/50 (22.0) | .54 |
Abdominal pain | 23/50 (46.0) | 13/50 (26.0) | .06 |
Cardiovascular | |||
Palpitation | 1/50 (2.0) | 0 | .25 |
Orthostatic hypotension | 4/49 (8.2) | 0 | .04 |
Infection | |||
Upper respiratory tract | 9/50 (18.0) | 9/50 (18.0) | .82 |
Influenza virus | 1/50 (2.0) | 2/51 (3.9) | .47 |
Others | 2/50 (4.0) | 0 | .21 |
Nervous system | |||
Fatigue | 1/50 (2.0) | 1/50 (2.0) | .81 |
Headache | 10/50 (20.0) | 8/50 (16.0) | .51 |
Dizziness | 4/50 (8.0) | 3/51 (5.9) | .95 |
Injection site | |||
Hematoma or pain | 0 | 3/51 (5.9) | .13 |
Musculoskeletal disorder | 3/49 (6.1) | 2/51 (3.9) | .47 |
Other | 2/50 (4.0) | 6/51 (11.8) | .20 |
Hypoglycemiac | 13/50 (26.0) | 7/50 (14.0) | .22 |
Serious adverse events | |||
Total No. | 6/51 (11.8) | 13/51 (25.5) | .04 |
Somatic disease | |||
Tonsillitis | 0 | 1/50 (2.0) | .39 |
Pneumonia | 2 (3.9) | 0 | .40 |
Bacterial gastroenteritis | 0 | 1/50 (2.0) | .40 |
Cholelithiasis | 0 | 1/50 (2.0) | .40 |
Hashimoto disease | 0 | 1/50 (2.0) | .40 |
Death | 1/52 (1.9) | 0 | .30 |
Psychiatric disease | |||
Admission to hospital for worsening of schizophrenia | 3/50 (6.0) | 951 (17.7) | .08 |
All participants who received at least 1 dose of liraglutide or placebo were included in the safety analyses.
Calculated using exact logistic regression adjusting for antipsychotic treatment (olanzapine, clozapine, or both).
Based on self-reported cases of hypoglycemia or plasma glucose levels less than 54 mg/dL (to convert to mmol/L, multiply by 0.0555) measured during the trial. All cases of measured hypoglycemia happened during the final oral glucose tolerance test in participants who had received placebo.