Table 3.
Characteristics of patients receiving at least one of the 49 anticancer drugs associated significantly with drug-induced long QT syndrome, torsade de pointes, or ventricular arrhythmias through 01 January 2019, in VigiBase
| Total N = 2301 | |
|---|---|
| Age at onset (years), median [IQR] | 63 [51–71] N = 1609 available |
| Time to onset (days), median [IQR] | 25 [7–97] N = 776 available |
| Reporting year | |
| 1973–1993 | 22/2301 (1.0%) |
| 1994–1998 | 34/2301 (1.5%) |
| 1999–2003 | 67/2301 (2.9%) |
| 2004–2008 | 191/2301 (8.3%) |
| 2009–2013 | 553/2301 (24%) |
| 2014–2018 | 1434/2301 (62.3%) |
| Notifier | |
| Healthcare professionals | 1701/1943 (88%) |
| Non-healthcare professionals | 242/1943 (12%) |
| Country of reporting | |
| Africa | 1/2301 (0.1%) |
| Americas | 1038/2301 (45.1%) |
| Asia | 423/2301 (18.4%) |
| Europe | 762/2301 (33.1%) |
| Oceania | 77/2301 (3.3%) |
| Sex | |
| Female | 931/2023 (46%) |
| Male | 1092/2023 (54%) |
| Type of report | |
| diLQT without TdP; % including SD | 1406/2301 (61%); 0/1406 (0%) |
| TdP; % including SD | 196/2301 (9%); 44/196 (29%) |
| VA (not TdP); % including SD | 699/2301 (30%); 184/699 (26%) |
| Seriousness | |
| Serious | 1946/2078 (94%) |
| Death | 317/2301 (14%) |
| SD | 228/2301 (10%) |
| Number of anticancer drug suspected/interacting | |
| 1 | 1793/2301 (78%) |
| 2 | 313/2301 (14%) |
| ≥3 | 195/2301 (8%) |
| Type of anticancer drugs suspected/interacting | |
| At least one cytotoxic | 621/2301 (27%) |
| At least one hormonotherapy | 138/2301 (6%) |
| At least one immunotherapy | 33/2301 (1.4%) |
| At least one kinase inhibitor | 1477/2301 (64.2%) |
| At least one miscellaneous drug | 300/2301 (13%) |
| 2 types or more combined | 258/2301 (11.2%) |
| Indications | |
| Chronic myeloid leukaemia (CML) | 363/1555 (23%) |
| Leukaemia other than CML | 272/1555 (17%) |
| Colorectal cancer | 126/1555 (8.1%) |
| Lung cancer | 114/1555 (7.3%) |
| Breast cancer | 104/1555 (6.7%) |
| Kidney cancer | 95/1555 (6.1%) |
| Melanoma | 90/1555 (5.8%) |
| Thyroid cancer | 76/1555 (4.9%) |
| Myeloma | 50/1555 (3.2%) |
| Lymphoma | 47/1555 (3%) |
| Prostate cancer | 24/1555 (1.5%) |
| Cancer other | 90/1555 (5.8%) |
| Cancer no precision | 52/1555 (3.3%) |
| Other hematological diseases or malignancies | 34/1555 (2.2%) |
| Indication other than malignancy (inflammatory or autoimmune diseases) | 18/1555 (1.2%) |
| Concurrent reported drugs at known risk of TdP (in the diLQT and/or TdP reports, n = 1602) | |
| 0 | 1381/1602 (86.2%) |
| 1 | 192/1602 (12%) |
| 2 | 18/1602 (1.1%) |
| ≥3 | 11/1602 (0.7%) |
| Concurrent reported drugs at conditional, possible or known risk of TdP(in the diLQT and/or TdP reports, n = 1602) | |
| 0 | 1157/1602 (72.2%) |
| 1 | 244/1602 (15.2%) |
| 2 | 103/1602 (6.4%) |
| ≥3 | 98/1602 (6.1%) |
| Classes of concurrently reported drugs at conditional, possible or known risk of TdP(in the diLQT and/or TdP reports, n = 1602) | |
| Anti-alpha1-adrenergics | 3/1602 (0.2%) |
| Antiarrhythmic | 41/1602 (2.6%) |
| Antidepressant | 96/1602 (6.0%) |
| Antiemetic | 119/1602 (7.4%) |
| Antihistamine | 36/1602 (2.2%) |
| Anti-infectious | 114/1602 (7.1%) |
| Antipsychotic | 23/1602 (1.4%) |
| Diuretic-potassium lowering agents | 96/1602 (6.0%) |
| Opioid | 73/1602 (4.6%) |
| Proton pump inhibitor | 137/1602 (8.6%) |
| Other cardiovascular drugs | 2/1602 (0.1%) |
| Others | 13/1602 (0.8%) |
| Concurrent reported condition favouring LQT/TdP or VA | |
| None | 1216/2301 (53%) |
| Hypokalemia | 107/2301 (4.7%) |
| Hypocalcemia | 65/2301 (2.8%) |
| Hypomagnesemia | 33/2301 (1.4%) |
| Diabetes mellitus | 39/2301 (1.7%) |
| Uncontrolled hypertension | 92/2301 (4%) |
| Pericarditis or pericardia effusion | 25/2301 (1.1%) |
| Cardiac ischaemia | 183/2301 (8%) |
| Heart failure | 239/2301 (10%) |
| Bradycardia | 94/2301 (4.1%) |
| Tachycardia | 113/2301 (4.9%) |
| Conductive disorders | 174/2301 (7.6%) |
| Atrial fibrillation | 126/2301 (5.5%) |
| Hypotension or shock | 134/2301 (5.8%) |
| Ischaemia or thrombosis (not cardiac nor cerebral) | 75/2301 (3.3%) |
| Acute kidney injury | 133/2301 (5.8%) |
| Acute hepatic injury | 139/2301 (6%) |
| Acute stroke | 43/2301 (1.9%) |
| Epilepsy | 43/2301 (1.9%) |
| Infection (virus, bacteria, fungus, or parasite) | 275/2301 (12%) |
| Inflammation | 160/2301 (7%) |
| Other cardiovascular disorders | 132/2301 (5.7%) |
diLQT, drug-induced long QT syndrome; SD, sudden death; TdP, torsade de pointes; VA, ventricular arrhythmia.