CVAEs reported in cohort and pharmacovigilance studies evaluating cellular therapies
| Study . | Study type . | Drug class . | Sample size . | Median follow-up duration, mo . | Rate of CRS∗ . | Reported rates of CVAEs . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arrhythmia . | Cardiac decompensation . | Left ventricular dysfunction . | Cardiac ischemia† . | Cardiomyopathy . | Cardiac death . | Hypertension . | Hypotension/shock . | Coagulopathy . | Others . | ||||||
| Burstein et al91 | Retrospective | CAR-T | 93 | 6‡ | 24 (25.8%) | NA | NA | 10 (10%) | NA | NA | NA | NA | 24 (25%) | NA | NA |
| Alvi et al82 | Retrospective | CAR-T | 137 | 10 | 81 (59%) | 5 (3.6%) | 6 (4.4%) | NA | NA | NA | 6 (4.4%) | NA | NA | NA | NA |
| Lefebvre et al83 | Retrospective | CAR-T | 145 | 15 | 104 (72%) | 11 (7.5%) | 22 (15%) | NA | 2 (1.4%) | NA | 2 (1.4%) | NA | NA | NA | NA |
| Shalabi et al85 | Retrospective | CAR-T | 52 | NA | 37 (71%) | NA | NA | 6 (12%) | NA | NA | NA | NA | 9 (17%) | NA | NA |
| Ganatra et al23 | Retrospective | CAR-T | 187 | 5.5 | 155 (83%) | 13 (7.0%) | NA | NA | NA | 12 (10.3%)§ | NA | NA | NA | NA | NA |
| Brammer et al87 | Retrospective | CAR-T | 90 | 16.5 | 80 (88.9%) | 11 (12.2%) | 1 (1.1%) | NA | NA | NA | NA | NA | NA | NA | 3 (3.3%); other myocarditis, 2 (2.2%) |
| Qi et al88 | Retrospective | CAR-T | 126 | 1.6‡ | 103 (81.7%) | 7 (6%) | 15 (12%) | 1 (1%) | 9 (7%) | NA | NA | NA | NA | NA | New valve disease, 1 (1%) |
| Goldman et al22 | Pharmacovigilance|| | CAR-T | 2657 | NA | 1457 (54.84%) | 74 (2.79%) | NA | NA | 12 (0.45%) | 69 (2.6%) | NA | 18 (0.68%) | 286 (10.76%) | NA | Cardiogenic shock, 49 (1.84%); pericardial disease, 11 (0.41%); myocarditis, 2 (0.08%) |
| Korell et al94 | Prospective | CAR-T | 137 | 8.8‡ | 75 (54.7%) | 5 (4%) | 17 (12%) | 4 (3%) | NA | NA | NA | 2 (1%) | 25 (18%) | NA | NA |
| Wudhikarn et al86 | Retrospective | CAR-T | 60 | 9 | NA | 8 (13.3%) | NA | 3 (5%) | NA | NA | NA | 5 (8.3%) | 28 (46.6%) | 8 (13.3%) | Pericardial effusion, 1 (1.67%) |
| Lefebvre et al93 | Prospective | CAR-T | 44 | 16 | 23 (52%) | 1 (1.67%) | 1 (1.67%) | NA | NA | NA | NA | NA | NA | NA | NA |
| Jung et al92 | Retrospective | BTE | 50 | NA | 10 (20%) | NA | NA | NA | NA | NA | NA | NA | NA | NA | 7 (14%)¶ |
| Sayed et al15 | Pharmacovigilance|| | BTE | 3668 | NA | NA | 45 (1.22%) | 52 (1.4%) | NA | NA | NA | NA | NA | 193 (5.26%) | NA# | Myocarditis, 8 (0.22%); pericarditis, 4 (0.1%) |
| Fradley et al90 | Retrospective | TIL | 43 | NA | NA | 6 (14%) | NA | NA | 1 (2.3%) | NA | NA | NA | 14 (32.6%) | NA | NA |
| Study . | Study type . | Drug class . | Sample size . | Median follow-up duration, mo . | Rate of CRS∗ . | Reported rates of CVAEs . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arrhythmia . | Cardiac decompensation . | Left ventricular dysfunction . | Cardiac ischemia† . | Cardiomyopathy . | Cardiac death . | Hypertension . | Hypotension/shock . | Coagulopathy . | Others . | ||||||
| Burstein et al91 | Retrospective | CAR-T | 93 | 6‡ | 24 (25.8%) | NA | NA | 10 (10%) | NA | NA | NA | NA | 24 (25%) | NA | NA |
| Alvi et al82 | Retrospective | CAR-T | 137 | 10 | 81 (59%) | 5 (3.6%) | 6 (4.4%) | NA | NA | NA | 6 (4.4%) | NA | NA | NA | NA |
| Lefebvre et al83 | Retrospective | CAR-T | 145 | 15 | 104 (72%) | 11 (7.5%) | 22 (15%) | NA | 2 (1.4%) | NA | 2 (1.4%) | NA | NA | NA | NA |
| Shalabi et al85 | Retrospective | CAR-T | 52 | NA | 37 (71%) | NA | NA | 6 (12%) | NA | NA | NA | NA | 9 (17%) | NA | NA |
| Ganatra et al23 | Retrospective | CAR-T | 187 | 5.5 | 155 (83%) | 13 (7.0%) | NA | NA | NA | 12 (10.3%)§ | NA | NA | NA | NA | NA |
| Brammer et al87 | Retrospective | CAR-T | 90 | 16.5 | 80 (88.9%) | 11 (12.2%) | 1 (1.1%) | NA | NA | NA | NA | NA | NA | NA | 3 (3.3%); other myocarditis, 2 (2.2%) |
| Qi et al88 | Retrospective | CAR-T | 126 | 1.6‡ | 103 (81.7%) | 7 (6%) | 15 (12%) | 1 (1%) | 9 (7%) | NA | NA | NA | NA | NA | New valve disease, 1 (1%) |
| Goldman et al22 | Pharmacovigilance|| | CAR-T | 2657 | NA | 1457 (54.84%) | 74 (2.79%) | NA | NA | 12 (0.45%) | 69 (2.6%) | NA | 18 (0.68%) | 286 (10.76%) | NA | Cardiogenic shock, 49 (1.84%); pericardial disease, 11 (0.41%); myocarditis, 2 (0.08%) |
| Korell et al94 | Prospective | CAR-T | 137 | 8.8‡ | 75 (54.7%) | 5 (4%) | 17 (12%) | 4 (3%) | NA | NA | NA | 2 (1%) | 25 (18%) | NA | NA |
| Wudhikarn et al86 | Retrospective | CAR-T | 60 | 9 | NA | 8 (13.3%) | NA | 3 (5%) | NA | NA | NA | 5 (8.3%) | 28 (46.6%) | 8 (13.3%) | Pericardial effusion, 1 (1.67%) |
| Lefebvre et al93 | Prospective | CAR-T | 44 | 16 | 23 (52%) | 1 (1.67%) | 1 (1.67%) | NA | NA | NA | NA | NA | NA | NA | NA |
| Jung et al92 | Retrospective | BTE | 50 | NA | 10 (20%) | NA | NA | NA | NA | NA | NA | NA | NA | NA | 7 (14%)¶ |
| Sayed et al15 | Pharmacovigilance|| | BTE | 3668 | NA | NA | 45 (1.22%) | 52 (1.4%) | NA | NA | NA | NA | NA | 193 (5.26%) | NA# | Myocarditis, 8 (0.22%); pericarditis, 4 (0.1%) |
| Fradley et al90 | Retrospective | TIL | 43 | NA | NA | 6 (14%) | NA | NA | 1 (2.3%) | NA | NA | NA | 14 (32.6%) | NA | NA |
ACS, acute coronary syndrome; MI, myocardial infarction; NA, not available.
Includes any-grade CRS.
Includes events reported as ACS or MI.
Reported as overall follow-up duration.
Percentage out of 116 patients with available imaging.
Reported rates from pharmacovigilance studies are the proportions representing the reporting of a particular AE of all drug-related AE reports.
Includes “cardiovascular disease/events” not otherwise specified.
Increased reporting odds of DIC events was found to be statistically significant; however, the proportion of reported events was not stated.