Comparison between early (<90 days) and late (≥90 days) CAE reports collected from VigiBase until January 30, 2019
| n avail | Early CAEs (n=437) | n avail | Late CAEs (n=159) | P value | |
| Completeness score of individual case safety reports | 437 | 0.81 (0.67–0.93) | 159 | 0.73 (0.63–0.90) | 0.058 |
| Age (years) | 344 | 68.0 (60.0–74.0) | 114 | 67.5 (60.0–74.0) | 0.956 |
| Male | 432 | 301 (69.7%) | 154 | 100 (64.9%) | 0.324 |
| Drug indication | 369 | 146 | 0.644 | ||
| Breast cancer | 0 (0.0) | 2 (1.4) | |||
| Digestive tract cancer | 1 (0.3) | 1 (0.7) | |||
| Glioblastoma | 1 (0.3) | 0 (0.0) | |||
| Gynecological cancer | 1 (0.3) | 1 (0.7) | |||
| Head and neck carcinoma | 4 (1.1) | 2 (1.4) | |||
| Hepatocellular carcinoma | 0 (0.0) | 1 (0.7) | |||
| Hodgkin's disease | 5 (1.4) | 2 (1.4) | |||
| Kaposi's syndrome | 0 (0.0) | 1 (0.7) | |||
| Lung cancer | 198 (53.7) | 74 (50.7) | |||
| Lymphoma | 1 (0.3) | 0 (0.0) | |||
| Melanoma | 95 (25.7) | 39 (26.7) | |||
| Mesothelioma | 3 (0.8) | 1 (0.7) | |||
| Neuroendocrine cancer | 1 (0.3) | 0 (0.0) | |||
| Other skin cancer | 3 (0.8) | 2 (1.4) | |||
| Renal cancer | 43 (11.7) | 16 (11.0) | |||
| Thymoma | 1 (0.3) | 0 (0.0) | |||
| Urothelial cancer | 12 (3.3) | 4 (2.7) | |||
| ICIs | 437 | 159 | 0.560 | ||
| Atezolizumab | 11 (2.5) | 5 (3.1) | |||
| Avelumab | 3 (0.7) | 2 (1.3) | |||
| Durvalumab | 15 (3.4) | 1 (0.6) | |||
| Ipilimumab | 39 (8.9) | 9 (5.7) | |||
| Nivolumab | 241 (55.1) | 96 (60.4) | |||
| Pembrolizumab | 93 (21.3) | 35 (22.0) | |||
| Nivolumab+ipilimumab | 32 (7.3) | 10 (6.3) | |||
| Pembrolizumab+ipilimumab | 2 (0.5) | 1 (0.6) | |||
| Pembrolizumab+nivolumab | 1 (0.2) | 0 (0.0) | |||
| Anti-PD-1 or anti-PD-L1 | 437 | 398 (91.1) | 159 | 150 (94.3) | 0.261 |
| Anti-CTLA-4 | 437 | 74 (16.9) | 159 | 20 (12.6) | 0.245 |
| Combination therapy | 437 | 35 (8.0) | 159 | 11 (6.9) | 0.789 |
| Time to onset after initiation of ICI (days) | 437 | 21 (8–44) | 159 | 177 (128–317) | <0.001 |
| Total number of infusions before cardiotoxicity, n | 154 | 2 (1–3) | 80 | 13 (8–20) | <0.001 |
| Type of cardiotoxicity | 437 | 159 | |||
| Cardiac conductive disorder | 12 (2.7) | 4 (2.5) | 1.000 | ||
| HF | 92 (21.1) | 50 (31.4%) | 0.012 | ||
| Cardiac supraventricular arrhythmias | 83 (19.0) | 20 (12.6) | 0.087 | ||
| Cardiac ventricular arrhythmias | 14 (3.2) | 4 (2.5) | 0.870 | ||
| Hypertension | 71 (16.2) | 20 (12.6) | 0.331 | ||
| Myocardial infarction | 60 (13.7) | 23 (14.5) | 0.924 | ||
| Cardiac death or shock | 58 (13.3) | 12 (7.5) | 0.076 | ||
| Torsades de pointes/QT prolongation | 8 (1.8) | 4 (2.5) | 0.844 | ||
| Cardiac valve disorders | 2 (0.5) | 2 (1.3) | 0.623 | ||
| Endocardial disorders | 3 (0.7) | 2 (1.3) | 0.866 | ||
| Myocarditis | 68 (15.6) | 24 (15.1) | 0.991 | ||
| Pericardial diseases | 50 (11.4) | 29 (18.2) | 0.043 | ||
| Associated immune-related events | 437 | 167 (38.2) | 159 | 72 (45.3) | 0.144 |
| Seriousness | 437 | 408 (93.4) | 159 | 154 (96.9) | 0.154 |
| Death (any cause) | 437 | 131 (30.0) | 159 | 43 (27.0) | 0.552 |
Data are n (%) or median (IQR).
CAE, cardiac adverse event; CTLA-4, cytotoxic T-lymphocyte antigen 4; HF, heart failure; ICI, immune checkpoint inhibitor; n avail, number of cases with available data; PD-1, programmed death 1; PD-L1, programmed death-ligand 1.