The new england journal of medicine Table 4. Adverse Events. LY-CoV555 Placebo Adverse Events (N = 309) (N = 143) 700 mg 2800 mg 7000 mg Pooled Doses (N = 101) (N = 107) (N = 101) (N = 309) number of patients (percent) Serious adverse events* 0 0 0 0 1 (0.7) Adverse events Any 24 (23.8) 23 (21.5) 22 (21.8) 69 (22.3) 35 (24.5) Mild 16 (15.8) 18 (16.8) 10 (9.9) 44 (14.2) 18 (12.6) Moderate 7 (6.9) 3 (2.8) 8 (7.9) 18 (5.8) 16 (11.2) Severe 0 2 (1.9) 3 (3.0) 5 (1.6) 1 (0.7) Missing data 1 (1.0) 0 1 (1.0) 2 (0.6) 0 Adverse events according to preferred term† Nausea 3 (3.0) 4 (3.7) 5 (5.0) 12 (3.9) 5 (3.5) Diarrhea 1 (1.0) 2 (1.9) 7 (6.9) 10 (3.2) 7 (4.9) Dizziness 4 (4.0) 3 (2.8) 3 (3.0) 10 (3.2) 3 (2.1) Headache 3 (3.0) 2 (1.9) 0 5 (1.6) 3 (2.1) Pruritus 2 (2.0) 3 (2.8) 0 5 (1.6) 1 (0.7) Vomiting 1 (1.0) 3 (2.8) 1 (1.0) 5 (1.6) 4 (2.8) Chills 0 1 (0.9) 3 (3.0) 4 (1.3) 0 Pyrexia 1 (1.0) 2 (1.9) 1 (1.0) 4 (1.3) 1 (0.7) Chest discomfort 1 (1.0) 1 (0.9) 1 (1.0) 3 (1.0) 1 (0.7) Fatigue 0 1 (0.9) 2 (2.0) 3 (1.0) 0 Hypertension 1 (1.0) 0 2 (2.0) 3 (1.0) 0 Lipase increased 1 (1.0) 0 2 (2.0) 3 (1.0) 0 Thrombocytosis 1 (1.0) 2 (1.9) 0 3 (1.0) 0 Blood pressure increased 2 (2.0) 0 0 2 (0.6) 0 Chest pain 1 (1.0) 1 (0.9) 0 2 (0.6) 0 Dyspepsia 1 (1.0) 0 1 (1.0) 2 (0.6) 0 Hypersensitivity 1 (1.0) 1 (0.9) 0 2 (0.6) 1 (0.7) Insomnia 0 1 (0.9) 1 (1.0) 2 (0.6) 0 Nasal congestion 1 (1.0) 1 (0.9) 0 2 (0.6) 1 (0.7) Rash 1 (1.0) 0 1 (1.0) 2 (0.6) 1 (0.7) Syncope 0 1 (0.9) 1 (1.0) 2 (0.6) 1 (0.7) * The serious adverse event in the placebo group was upper abdominal pain. There were no deaths during the trial. † The preferred terms were defined according to the Medical Dictionary for Regulatory Activities, version 23.0. and a lower symptom burden than those who Supported by Eli Lilly. received placebo, with the most pronounced ef- Disclosure forms provided by the authors are available with fects observed in high-risk cohorts. If these re- the full text of this article at NEJM.org. sults are confirmed in additional analyses in this A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. trial, LY-CoV555 could become a useful treatment We thank Adam Clooney, Ph.D., of Eli Lilly, for providing med- for emergency use in patients with recently diag- ical-writing and other editorial support with an earlier version nosed Covid-19. of the manuscript. 8 n engl j med nejm.org The New England Journal of Medicine Downloaded from nejm.org on November 19, 2020. For personal use only. No other uses without permission. Copyright © 2020 Massachusetts Medical Society. All rights reserved.