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. 2017 Jul 5;74(7):719–728. doi: 10.1001/jamapsychiatry.2017.1220

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
a

All participants who received at least 1 dose of liraglutide or placebo were included in the safety analyses.

b

Calculated using exact logistic regression adjusting for antipsychotic treatment (olanzapine, clozapine, or both).

c

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.