Table 1.
Overall characteristics of reports of myocarditis in the WHO pharmacovigilance database, VigiBase®.
| Number (%) | Navailable (%) | |
|---|---|---|
| Region reporting | All | |
| APAC | 1826/5108 (35.7%) | |
| Europe | 1658/5108 (32.5%) | |
| LATAM | 9/5108 (0.2%) | |
| MENA | 22/5108 (0.4%) | |
| North America | 1592/5108 (31.2%) | |
| Sub-Saharan Africa | 1/5108 (0.0%) | |
| Reporting year | All | |
| 1979–1989 | 23/5108 (0.5%) | |
| 1990–1999 | 104/5108 (2.1%) | |
| 2000–2009 | 899/5108 (17.9%) | |
| 2010–2020 | 4082/5108 (81.3%) | |
| Reporter qualification | 3153/5108 (61.7%) | |
| Health professional | 3055/3153 (96.9%) | |
| Non-health professional | 98/3153 (3.1%) | |
| Reporting type | All | |
| From investigational drug studies | 251/5108 (4.9%) | |
| Non-study related (real-life) | 4857/5108 (95.1%) | |
| Gender | 4866/5108 (95.3%) | |
| Men | 3592/4866 (73.8%) | |
| Women | 1274/4866 (26.2%) | |
| Age (median [IQR] (min–max) in years) | 35 [25; 50] (0–91) | 4337/5108 (84.9%) |
| Delay (median [IQR] (min–max) in days)a | 15 [10; 24] (1–8685) | 2267/5108 (44.4%) |
| Drug classb | All | |
| Antipsychotic | 3108/5108 (60.8%) | |
| Immunotherapy | 538/5108 (10.5%) | |
| Cytotoxic | 190/5108 (3.7%) | |
| Salicylate | 340/5108 (6.7%) | |
| Vaccine | 790/5108 (15.5%) | |
| Miscellaneous | 243/5108 (4.8%) | |
| Fatal outcomes | 524/5108 (10.3%) | All |
| Single drug suspected | 3704/5108 (72.5%) | All |
APAC Asia-Pacific, ICI immune checkpoint inhibitor, IQR interquartile range, LATAM Latin America, MENA Middle East and North Africa.
aDelay is computed between first intake of treatment and first sign reported of myocarditis.
bCases may present with multiple drug classes. Data are presented as number (proportion) unless noted otherwise.