Drug Safety
Antipsychotics And Torsadogenic Risk: Signals Emerging From The FDA Adverse Event Reporting System Database
Elisabetta Poluzzi, Emanuel Raschi, Ariola Koci, Ugo Moretti, Edoardo Spina, Elijah R Behr, Miriam Sturkenboom, Fabrizio De Ponti
Correspondence:
Electronic Supplementary Material
Table S1. Outcome Definition
List of outcomes used to investigate the torsadogenic potential of drugs.
Group 1. TORSADE DE POINTES1 – Torsade de Pointes
Group 2. QT INTERVAL ABNORMALITIES
2A – Symptomatic QT interval abnormalities
QT interval/U-wave abnormalitiesOR ECG repolarisation abnormalitiescharacterized by: (I) seriousness: death, life-threatening OR (II) fatal outcome not included in group 1 (documented by coding system or in the narratives*)
2B – Asymptomatic QT interval abnormalities
QT interval/U-wave abnormalitiesor ECG repolarisation abnormalities not already included in group 2A (documented by coding system or in the narratives*).
Group 3. VENTRICULAR FIBRILLATION/TACHYCARDIA
3A – Ventricular fibrillation OR Cardiac fibrillation not included in group 1 or 2 (documented by coding system or in the narratives*).
3B – Ventricular tachycardia OR Ventricular arrhythmia OR tachyarrhythmiacharacterized by: (I) fatal outcome or (II) seriousness: death or life-threatening not included in group 1 or 2 or 3A (documented by coding system or in the narratives*).
3C – Ventricular tachycardia OR Ventricular arrhythmia OR tachyarrhythmia not included in group 1 or 2 or 3A or 3B (documented by coding system or in the narratives*).
Group 4. SUDDEN CARDIAC DEATH
4A – Sudden cardiac deathORcardiac arrest ORsudden (unexpected) death not included in group 1 or 2 or 3 (documented by coding system or in the narratives*).
4B – Syncope (with fatal or life-threatening outcome) not included in group 1 or 2 or 3 or 4A.
* because the public version of the FDA_AERS database does not allow analysis of narratives, the search strategy was only based on automatic data-mining approach through the MedDRA coding system.
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