Table 1.
Adverse events through day 457
| Participants with at least one AE, n (%) | PROVENT | STORM CHASER | ||
|---|---|---|---|---|
| AZD7442 (N = 3461) |
Placebo (N = 1736) |
AZD7442 (N = 749) |
Placebo (N = 372) |
|
| AE | 2016 (58.2) | 1007 (58.0) | 348 (46.5) | 193 (51.9) |
| COVID-19a | 467 (13.5) | 234 (13.5) | 117 (15.6) | 53 (14.2) |
| Headache | 439 (12.7) | 211 (12.2) | 86 (11.5) | 52 (14.0) |
| Cough | 423 (12.2) | 179 (10.3) | 80 (10.7) | 46 (12.4) |
| Fatigue | 370 (10.7) | 166 (9.6) | 57 (7.6) | 39 (10.5) |
| AEs leading to study withdrawal | 2 (0.1) | 1 (0.1) | 0 | 0 |
| SAE | 215 (6.2) | 97 (5.6) | 20 (2.7) | 16 (4.3) |
| Related SAEb | 2 (0.1) | 0 | 0 | 0 |
| MAAE | 991 (28.6) | 439 (25.3) | 95 (12.7) | 52 (14.0) |
| AESIc | 103 (3.0) | 43 (2.5) | 4 (0.5) | 4 (1.1) |
| Injection site reactions | 83 (2.4) | 36 (2.1) | 4 (0.5) | 4 (1.1) |
| Cardiovascular eventsd | 19 (0.5) | 7 (0.4) | 0 | 0 |
| Anaphylaxis | 1 (< 0.1) | 0 | 0 | 0 |
| Death | 22 (0.6) | 10 (0.6) | 3 (0.4) | 2 (0.5) |
AE adverse event, AESI AE of special interest, COVID-19 coronavirus disease 2019, MAAE medically attended AE, SAE serious AE
One participant was randomly assigned to receive placebo but incorrectly received AZD7442, and was therefore assessed for safety in the AZD7442 group per protocol
aDoes not align with the number of COVID-19 events in the efficacy analysis, which required protocol-defined pre-specified qualifying symptoms plus a corresponding positive severe acute respiratory syndrome coronavirus 2 reverse transcription-polymerase chain reaction test. Here, simply the Medical Dictionary for Regulatory Activities terms are reported
bDetermined to be related to study drug and/or procedures in the judgement of the investigators
cAESIs in PROVENT included injection site and hypersensitivity reactions and specific cardiovascular events (cardiac ischemia, cardiac failure, and thrombotic events)
dSpecifically cardiac ischemia, cardiac failure, and thrombotic events from 1 December 2021