Electronic Supplementary Material 2

Article Title: Performance of the standardised MedDRA queries for case retrieval in the

French spontaneous reporting database

Journal name: Drug Safety

Authors: Hélène Géniaux, Denise Assaf, Ghada Miremont-Salamé, Bénédicte Raspaud,

Amandine Gouverneur, Philip Robinson, Antoine Pariente, Francesco Salvo

Corresponding Author: Hélène Géniaux, CHU de Bordeaux, 146, Rue Léo Saignat,

Bâtiment 1A Zone nord Site Carreire, BP36, 33076 Bordeaux Cedex, France Criteria used for gold standard constitution ADR YES NO MAYBE Agranulocytosis Absolute Neutrophil Count (ANC) ANC > 0.5 x 109/L (>500) Used only when is specified <0.5 x 109/L (<500) given information Neutropenia Grade IV ANC not specified even if does not fit with the ANC not specified but “severe neutropenia or other categories neutropenia” leuconeutropenia mentioned (YES/NO) Leucocytes <500 even if PNN not specified ANC is <0.5 x 109/L (<500) Agranulocytosis but complete Cytopenia without specifying blood count not provided PNN or other blood count Hb and ANC are low or Nothing specified on blood decreasing count Platelets count and ANC are low or decreasing Agranulocytosis but not drug ANC, platelets and Hb are also induced low (pancytopenia, aplasia bone marrow) Agranulocytosis mentioned in patient history prior to using the new medication

Osteonecrosis History of osteonecrosis Used only when Radiology and/or MRI verify before initiating the drug given information osteonecrosis does not fit with the other categories (YES/NO)

Demyelination Demyelination taking place in the History of demyelination Used only when central or the peripheral nervous disease before initiating the given information system after the introduction of a drug does not fit with the drug other categories Diseases or medical conditions (YES/NO) that occur as a result of demyelination such as multiple sclerosis, optic neuritis, leukoencephalopathies, GBS, etc.

MRI brain shows white matter lesions or plaques appearing after the introduction of a drug Psychosis Illusions, delusions or History or known diagnosis Used only when hallucination appearing after drug of schizophrenia given information therapy Infantile psychosis does not fit with the General signs and symptoms other categories (depression, agitation, (YES/NO) anxiety, disorganized speech, disorientation, aggressiveness, disinhibition)