There are two fields in the DRUG files that relate to drug names, including the “drugname” and the “prod_ai.” Given that FAERS is a spontaneous reporting system (SRS), drug names may be documented as generic names, chemical structure names, trade names, synonyms, code names, abbreviations, and even incorrect names (13 (link)). Therefore, before data mining, all drug name records were standardized in the DEMO files as generic names. Firstly, the “drugname” and “prod_ai” fields were mapped to the specific RxNorm concepts, which contain a single active ingredient by using MedEx-UIMA software (MedEx-UIMA 1.3.8, Vanderbilt University, United States) (14 (link)). Secondly, we merged the fields containing compound ingredients after the first step of processing by using python 3.8 (Python Software Foundation, Wilmington, United States), and the pharmacist manually standardized the drug names. Finally, the data cleaning of the DRUG table was completed by screening and checking once again, by using the DrugBank database (15 (link)). The target drugs are novel antineoplastic agents, including but not limited to the following types of drugs: small-molecule targeted drugs as well as monoclonal antibodies. To minimize the probability of false positives, we selected only “role_cod” fields that play the role of “primary suspect (PS).”
The “pt” field in the REAC table is the name of AE written in the Medical Dictionary for Regulatory Activities (MedDRA) and represented as the “Preferred Terms” (PTs). The Standardised MedDRA (MedDRA® trademark is registered by ICH, version 24.0) queries (SMQs) was employed to access PTs related to GIP (16 ). A total of 24 PTs were identified as target AE terms after referring to books and literature, as described below: “Duodenal perforation,” “Duodenal ulcer perforation,” “Duodenal ulcer perforation, obstructive,” “Gastric perforation,” “Gastric ulcer perforation, obstructive,” “Gastrointestinal perforation,” “Ileal perforation,” “Ileal ulcer perforation,” “Intestinal perforation,” “Jejunal perforation,” “Jejunal ulcer perforation,” “Large intestine perforation,” “Oesophageal perforation,” “Peptic ulcer perforation,” “Rectal perforation,” “Small intestinal perforation,” “Oesophageal ulcer perforation,” “Large intestinal ulcer perforation,” “Small intestinal ulcer perforation,” “Intestinal ulcer perforation,” “Diverticular perforation,” “Gastrointestinal ulcer perforation,” “Upper gastrointestinal perforation,” “Lower gastrointestinal perforation.”
The “pt” field in the REAC table is the name of AE written in the Medical Dictionary for Regulatory Activities (MedDRA) and represented as the “Preferred Terms” (PTs). The Standardised MedDRA (MedDRA® trademark is registered by ICH, version 24.0) queries (SMQs) was employed to access PTs related to GIP (16 ). A total of 24 PTs were identified as target AE terms after referring to books and literature, as described below: “Duodenal perforation,” “Duodenal ulcer perforation,” “Duodenal ulcer perforation, obstructive,” “Gastric perforation,” “Gastric ulcer perforation, obstructive,” “Gastrointestinal perforation,” “Ileal perforation,” “Ileal ulcer perforation,” “Intestinal perforation,” “Jejunal perforation,” “Jejunal ulcer perforation,” “Large intestine perforation,” “Oesophageal perforation,” “Peptic ulcer perforation,” “Rectal perforation,” “Small intestinal perforation,” “Oesophageal ulcer perforation,” “Large intestinal ulcer perforation,” “Small intestinal ulcer perforation,” “Intestinal ulcer perforation,” “Diverticular perforation,” “Gastrointestinal ulcer perforation,” “Upper gastrointestinal perforation,” “Lower gastrointestinal perforation.”
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