Table 3.
Schizophrenia, n (%) (n = 17) |
|||
---|---|---|---|
AE Categories | Frequency | Bother | Most Bothersomea |
Weight changes | 16 (94) | – | – |
Weight gain and/or increased appetite | 16 (94) | 12 (71) | 7 (41) |
Weight loss and/or decreased appetite | 4 (24) | 0 | 0 |
Low energy | 14 (82) | 12 (71) | 6 (35) |
EPS | 13 (77) | 10 (59) | 2 (12) |
Somnolence/sedation | 12 (71) | – | – |
Need to sleep/excessive sleep/excessive sleepiness | 11 (65) | 6 (35) | 1 (6) |
”Zombie-like”/”out of it” | 4 (24) | 2 (12) | 1 (6) |
Anxiety b | 11 (65) | 8 (47) | 6 (35) |
Mental anxiety | 7 (41) | 6 (35) | 6 (35) |
Physical anxiety | 4 (24) | 4 (24) | 2 (12) |
Social anxiety | 1 (6) | 0 | 1 (6) |
Cognitive issues | 10 (59) | 6 (35) | 3 (18) |
Sexual function | 10 (59) | – | – |
Increased sexual desire/activities | 2 (12) | 1 (6) | 1 (6) |
Reduced sexual desire or performance | 8 (47) | 4 (24) | 2 (12) |
Increased schizophrenia positive symptoms | 8 (47) | 7 (41) | 4 (24) |
Anticholinergic-related dryness | 7 (41) | – | – |
Dry eyes | 1 (6) | 0 | 0 |
Dry mouth | 6 (35) | 5 (29) | 3 (18) |
Dry skin | 0 | 0 | 0 |
Visual problems | 7 (41) | 4 (24) | 2 (12) |
Insomnia | 6 (35) | 5 (29) | 2 (12) |
Restlessness/akathisia | 6 (35) | 3 (18) | 3 (18) |
Disequilibrium | 5 (29) | 3 (18) | 1 (6) |
Cardiovascular | 5 (29) | – | – |
Hypertension | 4 (24) | 1 (6) | 1 (6) |
Hypotension | 1 (6) | 1 (6) | 1 (6) |
QT prolongation/skipped heartbeat | 0 | 0 | 0 |
Depressive symptoms | 4 (24) | 2 (12) | 2 (12) |
Pain | 4 (24) | 2 (12) | 1 (6) |
Bowel/digestive system changes | 4 (24) | – | – |
Constipation | 2 (12) | 0 | 0 |
Diarrhea | 2 (12) | 1 (6) | 1 (6) |
Nausea/vomiting | 1 (6) | 1 (6) | 0 |
Abnormal blood/laboratory test levels | 4 (24) | – | – |
Anemia | 1 (6) | 1 (6) | 1 (6) |
Hyperglycemia | 1 (6) | 1 (6) | 0 |
Hyperlipidemia | 2 (12) | 1 (6) | 1 (6) |
Irritability | 3 (18) | 2 (12) | 1 (6) |
Anger/aggression | 2 (12) | 2 (12) | 1 (6) |
Hypomania | 2 (12) | 2 (12) | 0 |
Hormonal | 2 (12) | 1 (6) | 1 (6) |
Otherc | 2 (12) | 1 (6) | 0 |
Major medical (diabetes) | 2 (12) | 1 (6) | 1 (6) |
Major medical (seizures) | 1 (6) | 1 (6) | 0 |
Flat/restricted affect | 1 (6) | 0 | 0 |
Social withdrawal | 1 (6) | 0 | 0 |
Major medical (hypothyroidism) | 0 | 0 | 0 |
Abbreviations: EPS extrapyramidal symptoms, QT the time between the start of the Q wave and the end of the T wave in the heart’s electrical cycle
a The top 5 AEs most frequently reported as most bothersome are highlighted in bold
b Anxiety is reported as the sum of the participants who endorsed any of the anxiety subcodes and also accounts for participants who reported “anxiety” without noting a subcode
c The category of “other” was created to represent select symptoms reported by 2 or fewer participants that were also not reported as most bothersome, most clinically important, or an AE of specific interest