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MedDRAMedical Dictionary for Regulatory Activities
MedDRAMedical Dictionary for Drug Regulatory Affairs
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We mapped the 39 side effects (PTs) into System Organ Class (SOC) level of MedDRA to extract their organ attributes.
REACTION Includes all adverse drug reactions coded by MedDRA terminology .
To identify cases of drug-induced ILD, the clinical and safety study databases were first searched for adverse event terms included in the standardized MedDRA query (SMQ) search for ILD (Table 1).
All serious adverse events (SAEs) and treatmentemergent adverse events (TEAEs) were reported according to terminology in the Medical Dictionary for Regulatory Activities (MedDRA), version 15.1.
All suspected ADRs were classified as MedDRA 15.0 preferred terms (developed under the auspices of the International Conference on Harmonization (ICH)) and grouped by System Organ Class (SOC) [32, 33].
Aside from WHO DD, ICRC-Weyer also offers medication coding purely within the WHO ATC classification system, as well as MedDRA and other specialist dictionaries for coding of Adverse Events, medical histories, signs, symptoms, and diseases.
The production plan must also take into account third-party sources of information and their licensing (such as built-in MedDRA dictionaries that help define coded entries), as well as confidential, proprietary or EU/HIPAA or otherwise protected information.
Adverse events were coded and tabulated using the latest version of the MedDRA system (12).
The centre is fully compliant with 21 CFR part 11 regulations and tools such as Oracle Clinical?, Remote Data Capture, SAS?, WHO-DD, MedDRA, , nQuery Advisor, Winonlin, ARK, Oracle Adverse Event reporting system, which are used for reliability and reproducibility.
Cardiovascular events were tabulated from the investigator-documented records of adverse events, which medical professionals classified according to regulatory standards into different categories by means of the Medical Dictionary for Regulatory Activities (MedDRA).
FDA codes all reported adverse events using a standardized international terminology, MedDRA (the Medical Dictionary for Regulatory Activities).
All adverse events were recorded using the Medical Dictionary for Regulatory Activities Terminology (MedDRA) by body system and preferred term.