Table 2.
Cardiac and Serious Adverse Events in the Modified Intention-to-Treat Population Between Remdesivir Group and Control Group
| Remdesivir (n = 410) | Control (n = 423) | HR (95% CI) [P Value] | HRa (95% CI) [P Value] | |||
|---|---|---|---|---|---|---|
| N Patients (%) | Event Rate (95% CI) | N Patients (%) | Event Rate (95% CI) | |||
| Any cardiac adverse events | 46 (11.2) | 0.076 (.062–.089) | 48 (11.3) | 0.075 (.061–.089) | 1.0 (.6–1.5) [.95] | 1.0 (.7–1.5) [.98] |
| Any serious cardiac adverse eventsb | 27 (6.6) | 0.043 (.036–.050) | 21 (5.0) | 0.042 (.034–.049) | 1.3 (.7–2.3) [.30] | 1.3 (.8–2.4) [.32] |
| Any nonserious cardiac adverse eventsc | 23 (5.6) | 0.039 (.031–.049) | 30 (7.1) | 0.040 (.031–.049) | 0.8 (.5–1.3) [.38] | 0.7 (.4–1.4) [.39] |
| Grades 1–2 | 14 (3.4) | 0.031 (.025–.039) | 25 (5.9) | 0.032 (.025–.039) | 0.6 (.3–1.1) [.10] | 0.6 (.3–1.1) [.10] |
| Grades 3–4 | 8 (2.0) | 0.010 (.007–.013) | 6 (1.4) | 0.009 (.007–.013) | 1.8 (.6–5.5) [.26] | 1.9 (.6–5.6) [.25] |
| Subclasses of cardiac events | ||||||
| Any arrhythmic events | 39 (9.5) | 0.062 (.050–.075) | 40 (9.5) | 0.062 (.049–.074) | 1.1 (.6–1.6) [.74] | 1.1 (.7–1.7) [.68] |
| Any serious arrhythmic events | 23 (5.6) | 0.033 (.026–.041) | 14 (3.3) | 0.032 (.024–.039) | 1.7 (.8–3.3) [.10] | 1.7 (.9–3.3) [.11] |
| Atrial fibrillation | 9 (2.2) | 6 (1.4) | ||||
| Bradycardia | 3 (0.7) | 2 (0.5) | ||||
| Tachycardia | 4 (1.0) | 2 (0.5) | ||||
| Ventricular tachycardia | 0 (0.0) | 2 (0.5) | ||||
| Arrhythmia not specified | 7 (1.7) | 2 (0.5) | ||||
| Any nonserious arrhythmic events | ||||||
| Grades 1–2 | 13 (3.2) | 0.027 (.022–.033) | 24 (5.7) | 0.028 (.022–.034) | 0.6 (.3–1.2) [.16] | 0.6 (.3–1.2) [.17] |
| Grades 3–4 | 7 (1.7) | 0.009 (.007–.012) | 5 (1.2) | 0.009 (.007–.012) | 1.4 (.4–4.5) [.52] | 1.5 (.5–4.6) [.51] |
| Any non-arrhythmic events | 10 (2.4) | 0.018 (.014–.021) | 12 (2.8) | 0.018 (.014–.021) | 0.8 (.3–1.9) [.70] | 0.9 (.4–2.0) [.71] |
| Any serious adverse events | 154 (37.6) | 0.380 (.342–.408) | 145 (34.3) | 0.372 (.339–.405) | 1.2 (.9–1.4) [.20] | 1.2 (.9–1.5) [.21] |
Abbreviations: CI, confidence interval; HR, hazard ratio.
aHRs adjusted for the severity of coronavirus disease 2019 at baseline based on the Cox model.
bPer protocol, a serious adverse event was defined as an adverse event that results in death, is life threatening, requires prolongation of existing hospitalization, results in persistent or significant disability or incapacity, consists of a congenital anomaly/birth defect, or is an important medical event.
cPer protocol, the severity (intensity) of all adverse events was graded using the Division of AIDS table, corrected version 2.1 (July 2017). Some patients experienced different grades of adverse events.