Distribution of patient-reported adverse events in both groups.
| Adverse drug reaction | Group A (n = 48) | Group B (n = 55) | p-value |
|---|---|---|---|
| Nausea and vomiting | 4 (8.3%) | 5 (9.1%) | 0.18 |
| Abdominal pain | 3 (6.3%) | 5 (9.1%) | 0.23 |
| Daytime sedation | 30 (62.5%) | 12 (21.8%) | 0.02 |
| Dry mouth | 15 (31.3%) | 18 (32.7%) | 0.54 |
| Weight gain (> 10%) | 5 (10.4%) | 1 (1.8%) | 0.04 |
| Blurred vision | 10 (20.8%) | 8 (14.5%) | 0.13 |
The totals exceed the number of patients because individual patients could report more than one adverse event.
We thank Monkwriter (https://monkwriter.com/) for providing professional assistance in scientific writing of this article.
SSS: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Visualization, Writing—original draft. AD: Data curation, Formal analysis, Validation, Writing—review & editing, Supervision. S Moitra: Methodology, Resources, Supervision, Writing—review & editing. S Mukherjee: Investigation, Resources, Writing—review & editing. NC: Resources, Validation, Writing—review & editing. SRJ: Supervision, Project administration, Funding acquisition. All authors read and approved the submitted version.
The authors declare that they have no conflicts of interest.
The study was approved by the Institutional Ethics Committee, Allergy and Asthma Treatment Centre, Moulali, Kolkata, West Bengal, India (approval no. HREC-AARC/37). Because of the retrospective design, the requirement of informed consent was waived. Our study was conducted in accordance with the principles outlined in the Declaration of Helsinki (2024 revision) as adopted by the World Medical Association.
As this was a retrospective study based on existing records, individual informed consent was waived by the Institutional Ethics Committee.
Not applicable.
The data supporting the findings of this study are available from the corresponding author upon reasonable request.
This study was funded by “Geno Pharmaceuticals Pvt. Ltd.”. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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