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. 2020 Oct 28:NEJMoa2029849. doi: 10.1056/NEJMoa2029849

Table 4. Adverse Events.

Adverse Events LY-CoV555
(N=309)
Placebo
(N=143)
700 mg
(N=101)
2800 mg
(N=107)
7000 mg
(N=101)
Pooled Doses
(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.