Table 3.
Adverse events in the safety analysis set
| Tixagevimab–cilgavimab (n=452) | Placebo (n=451) | ||
|---|---|---|---|
| Any adverse event* | 132 (29%) | 163 (36%) | |
| Mild | 67 (15%) | 65 (14%) | |
| Moderate | 34 (8%) | 50 (11%) | |
| Severe | 22 (5%) | 30 (7%) | |
| Total deaths | 6 (1%) | 6 (1%)† | |
| Acute myocardial infarction or acute left ventricular failure | 1 (<1%) | 0 | |
| Sudden cardiac death | 1 (<1%) | 0 | |
| COVID-19 pneumonia with outcome of death | 2 (<1%) | 4 (1%) | |
| COVID-19 with outcome of death | 1 (<1%) | 1 (<1%) | |
| COVID-19 pneumonia, superinfection bacterial, or septic shock | 0 | 1 (<1) | |
| Malignant disease progression | 1 (<1) | 0 | |
| Any serious adverse event including death | 33 (7%) | 54 (12%) | |
| Any treatment-related adverse event‡ | 23 (5%) | 21 (5%) | |
| Any adverse event leading to study withdrawal§ | 5 (1%) | 7 (2%) | |
| Common adverse events | |||
| COVID-19 pneumonia | 26 (6%) | 49 (11%) | |
| Headache | 5 (1%) | 2 (<1%) | |
| Any adverse event of special interest | 15 (3%) | 15 (3%) | |
| Injection site pain | 8 (2%) | 10 (2%) | |
| Injection site erythema | 2 (<1%) | 2 (<1%) | |
| Injection site discomfort | 2 (<1%) | 1 (<1%) | |
| Injection site bruising | 1 (<1%) | 1 (<1%) | |
| Injection site haematoma | 1 (<1%) | 1 (<1%) | |
| Injection site induration | 1 (<1%) | 0 | |
| Injection site inflammation | 1 (<1%) | 0 | |
| Injection site nodule | 1 (<1%) | 0 | |
| Injection site warmth | 0 | 1 (<1%) | |
Each participant is counted only once (based on their maximum reported intensity) within a treatment group.
This differs from the initial number of deaths shown in figure 1 because one death occurred after the data cutoff, but the adverse event began before the data cutoff, thus the outcome was recorded. This death is excluded from figure 1 because the record itself is after the data cutoff.
Possibly related, as assessed by the investigator. Includes adverse events that occurred through to the end of the study.
Two participants in the placebo group discontinued from the study due to adverse events. Percentages are based on the total numbers of participants in the treatment group. Participants with multiple events of the same preferred term are counted only once in that preferred term. Participants with events in more than one preferred term within the same system organ class are counted only once in that system organ class row. Includes adverse events that occurred through to the end of the study. Adverse events of special interest includes injection site reactions and anaphylaxis and other serious hypersensitivity reactions, including immune complex disease. See details in protocol section 8·3·4 in the appendix (p 21).