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. 2021 May 26;27(12):1826–1837. doi: 10.1016/j.cmi.2021.05.020

Table 3.

Summary of adverse events according treatment group in the modified intention-to-treat population

Overall (n = 579)
 Control (n = 148)
 Lopinavir/ritonavir (L/r) (n = 144)
 Lopinavir/ritonavir + interferon β-1a (L/r + IFN) (n = 144)
 Hydroxychloroquine (HCQ) (n = 143)
 L/r versus control p-value L/r + IFN versus control p-value HCQ versus control p-value
No. events/no. Patients No. patients (%) No. patients (%) No. patients (%) No. patients (%)
Any adverse events 2399/450 105 (70.9%) 119 (82.6%) 117 (81.3%) 109 (76.2%) 0.02 0.04 0.35
Any grade 3 or 4 adverse events 477/205 48 (32.4%) 56 (38.9%) 58 (40.3%) 43 (30.1%) 0.27 0.18 0.71
Any serious adverse events 608/274 57 (38.5%) 76 (52.8%) 78 (54.2%) 63 (44.1%) 0.02 0.01 0.34
Any serious adverse event related to the experimental treatmenta — — 27 (18.8%) 45 (31.3%) 25 (17.5%) — — —
Death related to the experimental treatmenta — — 1 (0.1%) 3 (2.1%) 0 (0%) — — —
Premature suspension or discontinuation of the experimental treatmentb 77 (13.3%) — 17 (11.8%) 43 (29.9%) 17 (11.9%) — — —
Most relevant serious adverse events:

  • - Acute respiratory failure

 65/65 18 (12%) 19 (13%) 17 (12%) 11 (8%)

  • - Acute respiratory distress syndrome

 47/46 16 (11%) 7 (5%) 10 (7%) 13 (9%)

  • - Acute kidney injuryc

50/50 9 (6%) 16 (11%) 11 (8%) 14 (10%)

  • - Acute renal failure based on the RIFLE classification

 17/17 3 (2%) 3 (2%) 8 (6%) 3 (2%)

  • - Arrhythmia

 41/35 3 (2%) 8 (6%) 12 (8%) 12 (8%)

  • - Pulmonary embolism

 27/27 6 (4%) 10 (7%) 5 (3%) 6 (4%)

  • - Transaminases increased

 25/25 2 (1%) 5 (3%) 12 (8%) 6 (4%)

  • - Sepsis

 21/21 2 (1%) 6 (4%) 7 (5%) 6 (4%)

  • - Cholestasis

 6/6 0 (0%) 2 (1%) 3 (2%) 1 (1%)

In the ‘Overall’ column, numbers refer to number of events and number of patients. In other columns, numbers refer to number of patients (%). Some patients had more than a single serious adverse event. Analyses were performed on the modified intention-to-treat population. P-value refer to Fisher exact test.

a

According to the investigator's judgement. Among participants with the occurrence of the serious adverse event related to the experimental treatment, 14 (51.9%) in the lopinavir/ritonavir arm, 32 (71.1%) in the lopinavir/ritonavir plus IFN-β-1a arm and 12 (48.0%) in the hydroxychloroquine arm discontinued the experimental treatment.

b

Including renal failure in 30 patients, hepatic disorders in 18 patients and electrocardiogram abnormalities in eight patients. IFN treatment was completed in all patients from the lopinavir/ritonavir + interferon β-1a arm.

c

Excluding acute renal failures defined based on the RIFLE classification.