Any AE | 251 (82.8) | 251 (83.4) |
Headache | 61 (20.1) | 71 (23.6) |
Productive cough | 72 (23.8) | 70 (23.3) |
Myalgia | 60 (19.8) | 60 (19.9) |
Rhinorrhoea | 54 (17.8) | 58 (19.3) |
Oropharyngeal pain | 47 (15.5) | 55 (18.3) |
Arthralgia | 54 (17.8) | 54 (17.9) |
Wheezing | 35 (11.6) | 45 (15.0) |
Fatigue | 40 (13.2) | 39 (13.0) |
Cough | 28 (9.2) | 39 (13.0) |
Chest pain | 52 (17.2) | 37 (12.3) |
Dyspnoea | 42 (13.9) | 30 (10.0) |
Any AE related to treatment | 77 (25.4) | 68 (22.6) |
Headache | 16 (5.3) | 17 (5.6) |
Any AE leading to discontinuation of study treatment | 23 (7.6) | 24 (8.0) |
COVID-19 pneumonia | 1 (0.3) | 5 (1.7) |
COVID-19 | 3 (1.0) | 2 (0.7) |
Respiratory failure | 3 (1.0) | 5 (1.7) |
Acute respiratory failure | 3 (1.0) | 0 |
Any severe AE | 42 (13.9) | 34 (11.3) |
Respiratory failure | 9 (3.0) | 7 (2.3) |
COVID-19 | 5 (1.7) | 7 (2.3) |
COVID-19 pneumonia | 5 (1.7) | 7 (2.3) |
Pneumonia | 0 | 3 (1.0) |
Dyspnoea | 0 | 3 (1.0) |
Acute respiratory failure | 7 (2.3) | 1 (0.3) |
Any serious AE | 55 (18.2) | 38 (12.6) |
COVID-19 | 8 (2.6) | 11 (3.7) |
Respiratory failure | 9 (3.0) | 9 (3.0) |
COVID-19 pneumonia | 8 (2.6) | 8 (2.7) |
Acute kidney injury | 2 (0.7) | 3 (1.0) |
Pneumonia | 0 | 3 (1.0) |
Acute respiratory failure | 7 (2.3) | 1 (0.3) |
Pulmonary embolism | 5 (1.7) | 0 |
Any serious AE related to treatment | 3 (1.0) | 3 (1.0) |
Any fatal AE | 16 (5.3) | 16 (5.3) |
COVID-19 | 3 (1.0) | 5 (1.7) |
COVID-19 pneumonia | 2 (0.7) | 4 (1.3) |
Any fatal AE related to treatment | 0 | 0 |