Table 1.
Clinical Symptoms of PDSS Events--Grouped | Presented Initially N (%) |
Occurred at Any Time N (%) |
---|---|---|
Sedation (e.g., somnolence, sedation, unconsciousness) | 12 (40) | 26 (87) |
Delirium (combined) | 14 (47) | 29 (97) |
Speech Impairment (e.g., dysarthria) | 7 (23) | 21 (70) |
Motor Impairment (e.g., ataxia) | 7 (23) | 12 (40) |
Cognitive Impairment (e.g., confusion, disorientation) | 8 (27) | 17 (57) |
EPS, akathisia, tension or cramps in extremities | 3 (10) | 7 (23) |
Agitation, aggression, irritability, anxiety, restlessnessa | 2 (7) | 9 (30) |
General malaise (e.g., weak, dizzy, felt bad) | 19 (63) | 20 (67) |
Hypertension | 1 (3) | 2 (7) |
Possible seizure/convulsions | 0 (0) | 2 (7) |
Abbreviations: e.g. = for example; EPS = extrapyramidal symptoms; N = number of patients; PDSS = post-injection delirium/sedation syndrome.
a Restlessness may also be a manifestation of EPS (akathisia).