TABLE 1.
Characteristics of patients with ICI-associated cardiac arrhythmias sourced from the FAERS database (January 2017 to June 2021).
| Characteristics | Total reports, n (%) | Fatal cases, n (%) | Non-fatal cases, n (%) | p-value | |
|---|---|---|---|---|---|
| Total | 1957 | 617 | 1340 | ||
| Patient age (year) | — | NS | |||
| Median (IQR) | 68 (60-75) | 69 (61-75) | 68 (60-75) | ||
| < 18 | 28 (1.43%) | 13 (2.11%) | 15 (1.12%) | ||
| 18–64 | 591 (30.20%) | 174 (28.20%) | 417 (31.12%) | ||
| 65–74 | 631 (32.24%) | 200 (32.41%) | 431 (32.16%) | ||
| ≥75 | 445 (22.74%) | 146 (23.66%) | 299 (22.31%) | ||
| Unknown | 262 (13.39%) | 84 (13.61%) | 178 (13.28%) | ||
| Gender | — | 0.009 | |||
| Female | 602 (30.76%) | 160 (25.93%) | 442 (32.99%) | ||
| Male | 1261 (64.44%) | 431 (69.85%) | 830 (61.94%) | ||
| Unknown | 94 (4.80%) | 26 (4.21%) | 68 (5.07%) | ||
| Reporting year | — | NS | |||
| 2017 | 262 (13.39%) | 88 (14.26%) | 174 (12.99%) | ||
| 2018 | 461 (23.56%) | 151 (24.47%) | 310 (23.13%) | ||
| 2019 | 528 (26.98%) | 160 (25.93%) | 368 (27.46%) | ||
| 2020 | 562 (28.72%) | 174 (28.20%) | 388 (28.96%) | ||
| 2021 | 144 (7.36%) | 44 (7.13%) | 100 (7.46%) | ||
| Tumor Indications | — | 0.002 | |||
| Lung, pleura, thymus and heart | 744 (38.02%) | 262 (42.46%) | 482 (35.97%) | ||
| Urinary system and male genital organs | 310 (15.84%) | 85 (13.78%) | 225 (16.79%) | ||
| Digestive system | 130 (6.64%) | 59 (9.56%) | 71 (5.30%) | ||
| Haematopoietic and lymphoid tissues | 88 (4.50%) | 28 (4.54%) | 60 (4.48%) | ||
| Head and neck | 61 (3.12%) | 25 (4.05%) | 36 (2.69%) | ||
| Endocrine organs | 25 (1.28%) | 3 (0.49%) | 22 (1.64%) | ||
| Gynecologic organs | 96 (4.91%) | 19 (3.08%) | 77 (5.75%) | ||
| Skin | 267 (13.64%) | 76 (12.32%) | 191 (14.25%) | ||
| Central nervous system | 15 (0.77%) | 3 (0.49%) | 12 (0.90%) | ||
| Unspecified or unknown indication | 221 (11.29%) | 57 (9.24%) | 164 (12.24%) | ||
| Area | — | p < 0.001 | |||
| Africa | 4 (0.20%) | 1 (0.16%) | 3 (0.22%) | ||
| Asia | 388 (19.83%) | 163 (26.42%) | 225 (16.79%) | ||
| Europe | 661 (33.78%) | 190 (30.79%) | 471 (35.15%) | ||
| North America | 799 (40.83%) | 233 (37.76%) | 566 (42.24%) | ||
| Oceania | 47 (2.40%) | 6 (0.97%) | 41 (3.06%) | ||
| South America | 54 (2.76%) | 23 (3.73%) | 31 (2.31%) | ||
| Unknown | 4 (0.20%) | 1 (0.16%) | 3 (0.22%) | ||
| Reporters | — | NS | |||
| Physician | 808 (41.29%) | 273 (44.25%) | 535 (39.93%) | ||
| Pharmacist | 120 (6.13%) | 32 (5.19%) | 88 (6.57%) | ||
| Other health–professional | 666 (34.03%) | 194 (31.44%) | 472 (35.22%) | ||
| Consumer or Non–health professional | 344 (17.58%) | 109 (17.67%) | 235 (17.54%) | ||
| Unknown | 19 (0.97%) | 9 (1.46%) | 10 (0.75%) | ||
| ICI drug as suspected drug | — | NS | |||
| Monotherapy | 1579 (80.68%) | 490 (79.42%) | 1089 (81.27%) | NS | |
| Anti–CTLA–4 monotherapy | 40 (2.04%) | 12 (1.94%) | 28 (2.09%) | ||
| Ipilimumab | 37 (1.89%) | 12 (1.94%) | 25 (1.87%) | ||
| Tremelimumab | 3 (0.15%) | 0 (0.00%) | 3 (0.22%) | ||
| Anti–PD–1 monotherapy | 1145 (58.51%) | 345 (55.92%) | 800 (59.70%) | ||
| Nivolumab | 659 (33.67%) | 193 (31.28%) | 466 (34.78%) | ||
| Pembrolizumab | 479 (24.48%) | 148 (23.99%) | 331 (24.70%) | ||
| Cemiplimab | 7 (0.36%) | 4 (0.65%) | 3 (0.22%) | ||
| Anti–PD–L1 monotherapy | 394 (20.13%) | 133 (21.56%) | 261 (19.48%) | ||
| Atezolizumab | 246 (12.57%) | 81 (13.13%) | 165 (12.31%) | ||
| Avelumab | 51 (2.61%) | 19 (3.08%) | 32 (2.39%) | ||
| Durvalumab | 97 (4.96%) | 33 (5.35%) | 64 (4.78%) | ||
| Combination therapy | 378 (19.32%) | 127 (20.58%) | 251 (18.73%) | NS | |
| Ipilimumab+Nivolumab | 349 (17.83%) | 111 (17.99%) | 238 (17.76%) | ||
| Tremelimumab+Durvalumab | 29 (1.48%) | 16 (2.59%) | 13 (0.97%) | ||
| Concurrent cardiotoxicity | 0.001 | ||||
| Cardiac failure | 178 (9.10%) | 59 (9.53%) | 119 (8.85%) | ||
| Coronary artery disorders | 99 (5.06%) | 31 (5.01%) | 68 (5.06%) | ||
| Myocardial disorders | 189 (9.66%) | 55 (8.89%) | 134 (9.97%) | ||
| Pericardial disorders | 62 (3.17%) | 13 (2.10%) | 49 (3.65%) | ||
| Cardiac valve disorders | 9 (0.46%) | 0 (0.00%) | 9 (0.67%) |
Abbreviations: FAERS, Food and Drug Administration's Adverse Event Reporting System; ICI, immune checkpoint inhibitor; IQR: interquartile range; N: number of records.