For adverse event selection, we focused exclusively on the Preferred Term (PT) “Agranulocytosis” according to MedDRA version 27.0. While the Standardized MedDRA Query (SMQ) of agranulocytosis could ...

We employed the System Organ Classes (SOCs) and selected the Preferred Terms (PTs) from the Medical Dictionary for Regulatory Activities (MedDRA version 26.1). Results: A total of 11,298 cases were ...

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AEs were coded according to MedDRA V.22.0. Severity was classified according to DAIDS V.2.1. AEs were followed up until clinical resolution or judged to be chronic and stable while receiving care.