Table 2. Open in new tab Cardiac and...

	Remdesivir (n = 410)	Control (n = 423)	HR (95% CI) [P Value]	HR^a (95% CI) [P Value]
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 events^b	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 events^c	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]

Remdesivir (n = 410)

Control (n = 423)

HR (95% CI) [P Value]

HR^a (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 events^b

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 events^c

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]

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]

	Remdesivir (n = 410)	Control (n = 423)	HR (95% CI) [P Value]	HR^a (95% CI) [P Value]
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 events^b	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 events^c	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]

Table 2.

Open in new tab

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]	HR^a (95% CI) [P Value]
	N Patients (%)	Event Rate (95% CI)	N Patients (%)	Event Rate (95% CI)	HR (95% CI) [P Value]	HR^a (95% CI) [P Value]
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 events^b	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 events^c	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]

	Remdesivir (n = 410)		Control (n = 423)		HR (95% CI) [P Value]	HR^a (95% CI) [P Value]
	N Patients (%)	Event Rate (95% CI)	N Patients (%)	Event Rate (95% CI)	HR (95% CI) [P Value]	HR^a (95% CI) [P Value]
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 events^b	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 events^c	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.

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