Figure 2: Exhaustive annotation of ADRs using Brat.
From: A dataset of 200 structured product labels annotated for adverse drug reactions
The ADRs ‘hepatic reactions’ and ‘acute liver failure’ are attributed to the drug class of the label drug SIMPONI ARIA (golimumab), but not to the drug itself. The ALT elevations are annotated as asserted for the label drug and their severities are also annotated. The liver enzyme elevations are not annotated because they are mentioned as background information for the other drugs also taken by the patients in the Phase 3 of the trial. Note, that per FDA guidance, we annotated the abnormal results of the laboratory tests: ALT elevations. For some applications, this information might not be of interest. If desired, these ADRs can be excluded based on the mapping to the UMLS concept C1443982 [ALT (SGPT) level raised] that is of the semantic type Laboratory or Test Result.
