- 1 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In an observational and interview study (NCT03110471) of 30 patients conducted between September 2017 and March 2018, 8 patients (4 men and 4 women) aged 63−95 years were described, who developed fall, tremor, mood disorder, aggression, incontinence, seizures, insomnia, eczema, irritability, weight gain, hyperphagia, restlessness, cold feeling, hyper-salivation, postural hypotension, over sedation or confusion during treatment with diazepam, haloperidol, levetiracetam, memantine, mirtazapine, promazine, propranolol, quetiapine, risperidone, sertraline, tamsulosin, brinzolamide/timolol or venlafaxine [duration of treatments to reactions onset not stated; not all routes, dosages, indications and outcomes stated].
Participant 1.1: A 66-year-old man developed hyperphagia,...
- Jordan S, et al. Nurse-led medicines'; monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study. PLOS One 14: 1-27, No. 9, 11 Sep 2019. Available from: URL: http://doi.org/10.1371/journal.pone.0220885 - Wales