Table 3 Serious adverse events through day 90

Serious adverse events (SAEs)

148

46 (33.1)

155

51 (37.5)

0.93 (0.74–1.17)

Respiratory, thoracic and mediastinal disorders

51

52

Acute respiratory distress syndrome

21

21

Pulmonary embolism

8

13

Respiratory failure

13

7

Pneumothorax

3

5

Hypoxia

1

2

Respiratory distress

0

2

Acute respiratory failure

1

0

Haemoptysis

1

0

Obstructive airways disorder

1

0

Pleural effusion

1

0

Pleuritic pain

1

0

Pneumonitis

0

1

Pulmonary hypertension

0

1

Infections and infestations

63

54

Pneumonia

26

25

Pneumonia bacterial

10

8

Septic shock

8

4

Bacteraemia

4

6

Bronchopulmonary aspergillosis

0

3

COVID-19 pneumonia

3

0

Sepsis

1

2

Cytomegalovirus infection reactivation

2

0

Fungaemia

2

0

Superinfection bacterial

1

1

Bacterial infection

1

0

Candida pneumonia

1

0

Device related bacteraemia

1

0

Disseminated aspergillosis

0

1

Hepatitis B reactivation

0

1

Herpes simplex

1

0

Infectious pleural effusion

0

1

Mediastinitis

1

0

Prostatitis Escherichia coli

0

1

Septic arthritis staphylococcal

0

1

Staphylococcal bacteraemia

1

0

General disorders and administration site conditions

8

5

Multiple organ dysfunction syndrome

6

5

Chest pain

1

0

Death

1

0

Renal and urinary disorders

10

13

Acute renal failure

7

4

Acute kidney injury

2

6

Renal failure

1

2

Chronic kidney disease

0

1

Blood and lymphatic system disorders

0

4

Anaemia

0

2

Bicytopenia

0

1

Thrombocytopenia

0

1

Cardiac disorders

5

5

Cardiac disorder

2

2

Cardiac failure

1

1

Acute coronary syndrome

0

1

Acute myocardial infarction

0

1

Bradycardia

1

0

Myocarditis / pericarditis

1

0

Injury, poisoning and procedural complications

0

1

Hand fracture

0

1

Nervous system disorders

2

3

Coma

2

0

Facial paralysis

0

1

Haemorrhage intracranial

0

1

Subarachnoid haemorrhage

0

1

Gastrointestinal disorders

0

3

Ileus

0

1

Intestinal ischaemia

0

1

Rectal haemorrhage

0

1

Vascular disorders

4

4

Deep vein thrombosis

2

3

Circulatory collapse

1

0

Hypotension

1

0

Peripheral artery thrombosis

0

1

Congenital, familial and genetic disorders

0

1

Atrial septal defect

0

1

Investigations

5

9

Transaminases increased

4

8

Blood bilirubin increased

0

1

C-reactive protein increased

1

0

Musculoskeletal and connective tissue disorders

0

1

Spondylolisthesis

0

1

Drug-related SAEs

41

25 (18.0)

59

28 (20.6)

0.77 (0.52–1.16)

Respiratory, thoracic and mediastinal disorders

10

14

Pulmonary embolism

5

8

Respiratory failure

2

2

Acute respiratory distress syndrome

1

2

Acute respiratory failure

1

0

Obstructive airways disorder

1

0

Pneumonitis

0

1

Pneumothorax

0

1

Renal and urinary disorders

3

6

Acute kidney injury

2

5

Chronic kidney disease

0

1

Renal failure

1

0

Infections and infestations

22

23

Pneumonia

8

9

Pneumonia bacterial

5

3

Bacteraemia

0

3

Cytomegalovirus infection reactivation

2

0

Sepsis

1

1

Superinfection bacterial

1

1

Bacterial infection

1

0

Bronchopulmonary aspergillosis

0

1

COVID-19 pneumonia

1

0

Candida pneumonia

1

0

Hepatitis B reactivation

0

1

Infectious pleural effusion

0

1

Mediastinitis

1

0

Prostatitis Escherichia coli

0

1

Septic arthritis staphylococcal

0

1

Septic shock

0

1

Staphylococcal bacteraemia

1

0

General disorders and administration site conditions

1

3

Multiple organ dysfunction syndrome

1

3

Blood and lymphatic system disorders

0

2

Anaemia

0

1

Bicytopenia

0

1

Cardiac disorders

1

1

Acute coronary syndrome

0

1

Cardiac failure

1

0

Investigations

2

8

Transaminases increased

1

7

Blood bilirubin increased

0

1

C-reactive protein increased

1

0

Vascular disorders

2

2

Deep vein thrombosis

1

1

Circulatory collapse

1

0

Peripheral artery thrombosis

0

1