Table 1.
Reference sets created and used by pharmacovigilance methodological studies.
| Reference set | Data source | Drugs, n | ADRsa | Vocabulary | |||
|
|
|
|
ADRs, n | Drug-ADR pairs, n | Positive cases, n | Negative cases, n |
|
| RS-ADRb | Laboratory test and event (symptom) | 1344 | 4485 | 6,027,840 | 141,729 | 2330 | ATCc, MedDRAd, WHO-ARTe, LOINCf, and ICDg |
| Harpaz et al [13], 2012 | Event (symptom) | 44 | 38 | 137 | 62 | 75 | RxNorm, and MedDRA |
| Yoon et al [14], 2012 | Laboratory test | 10 | 51 | 510 | —h | — | None |
| Liu et al [15], 2013 | Laboratory test | 9 | 42 | 378 | — | — | None |
| LePendu et al [16], 2013 | Event (symptom) | 78 | 12 | 193 | 28 | 165 | MedDRA |
| Alvarez et al [28], 2010 | Event (symptom) | 267 | — | — | 532 | — | MedDRA |
| Hochberg et al [29], 2009 | Event (symptom) | 35 | — | — | 6207 | — | MedDRA |
| Ryan et al [30], 2012 (OMOPi version 1) | Event (symptom) | 10 | 9 | 90 | 9 | 44 | None |
| Ryan et al [18], 2013 (OMOP version 2) | Event (symptom) | 191 | 4 | 398 | 165 | 234 | None |
| Coloma et al [10], 2013 (EU-ADR) | Event (symptom) | 66 | 10 | 94 | 43 | 50 | None |
| Boyce et al [19], 2014 (OHDSIj knowledge base) | Event (symptom) | 1000 | 100 | 100,000 | — | — | ATC, RxNorm, and ICD |
aADR: adverse drug reaction.
bRS-ADR: reference standard for adverse drug reaction.
cATC: Anatomical Therapeutic Chemical.
dMedDRA: Medical Dictionary for Regulatory Activities.
eWHO-ART: World Health Organization Adverse Reactions Terminology.
fLOINC: Logical Observation Identifiers Names and Codes.
gICD: International Classification of Diseases.
hNot available.
iOMOP: Observational Medical Outcomes Partnership.
jOHDSI: Observational Health Data Sciences and Informatics.