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.