Table 2.
Adverse events through to day 169 (safety analysis set)
| Event, n (%)a | AZD7442 (N = 452) | Placebo (N = 451) |
|---|---|---|
| Any AE | 174 (38.5) | 196 (43.5) |
| Mild | 84 (18.6) | 82 (18.2) |
| Moderate | 54 (11.9) | 61 (13.5) |
| Severe | 26 (5.8) | 34 (7.5) |
| Any AE with outcome of death | 7 (1.5) | 6 (1.3) |
| Acute left ventricular failure | 1 (0.2) | 0 |
| Sudden cardiac death | 1 (0.2) | 0 |
| COVID-19 pneumonia | 2 (0.4) | 4 (0.9) |
| COVID-19 | 1 (0.2) | 1 (0.2) |
| Septic shock | 0 | 1 (0.2) |
| Colorectal cancer metastatic | 1 (0.2) | 0 |
| Gastric cancer | 1 (0.2) | 0 |
| Any SAE (including death) | 40 (8.8) | 61 (13.5) |
| Cardiac SAE | 2 (0.4) | 3 (0.7) |
| Any treatment-related AEb | 23 (5.1) | 21 (4.7) |
| Any AE leading to study withdrawal | 5 (1.1) | 7 (1.6) |
| Most common AEs | ||
| COVID-19 pneumonia | 26 (5.8) | 49 (10.9) |
| Diarrhea | 8 (1.8) | 5 (1.1) |
| Injection site pain | 8 (1.8) | 11 (2.4) |
| Type 2 diabetes mellitus | 8 (1.8) | 5 (1.1) |
| COVID-19c | 7 (1.5) | 15 (3.3) |
| Vaccination complication | 7 (1.5) | 9 (2.0) |
| Headache | 7 (1.5) | 4 (0.9) |
| Diabetes mellitus inadequate control | 7 (1.5) | 4 (0.9) |
| Any AESId | 15 (3.3) | 15 (3.3) |
| Injection site pain | 8 (1.8) | 11 (2.4) |
Data cutoff, 14 January 2022. The safety analysis set comprised all participants who received study drug, regardless of baseline hospitalization status (hospitalization was only allowed for isolation purposes)
AE adverse event, AESI AE of special interest, COVID-19 coronavirus disease 2019, SAE serious AE
aParticipants with multiple events in the same category are counted only once in that category, and participants with events in more than one category are counted once in each of those categories
bPossibly related, as assessed by the investigator
cReported after day 29 [most of these AEs were sequelae from the index COVID-19; COVID-19 re-infection was confirmed in 1 (0.2%) participant in each of the AZD7442 and placebo groups]
dIncludes anaphylaxis and other hypersensitivities, injection site pain, injection site erythema, and injection site discomfort