Table 2 Mortality and safety endpoints in the safety population

Number of patients

54

24

Mortality

 All-cause mortality at day 28

5 (9)

5 (21)

 All-cause mortality at 12–22 weeks

7 (13)

5 (21)

Serious adverse events (SAEs)

 Incidence of SAEs at day 28

7 (13)

5 (21)

 Incidence of SAEs at 12–22 weeks

10 (19)

5 (21)

All SAEs leading to mortality at 12–22 weeks

 Covid-19

4 (7)

3 (13)

 Infectious disorder (not COVID-19)

2 (4)

1 (4)

 Thrombosis

0

1 (4)

 Multi-organ failure

1 (2)

0

All SAEs not leading to mortality at 12–22 weeks*

 Infectious disorder (not COVID-19)

3 (6)

0

 Acute kidney injury

1 (2)

1 (4)

 Cardiac disorder

1 (2)

0

Nosocomial or invasive fungal infection^a

 Incidence at day 28

10 (19)

4 (17)

Adverse events

 Incidence at day 28

39 (72)

17 (71)

Adverse events with incidence > 10%

 Constipation

7 (13)

5 (21)

 Hypertension

8 (15)

2 (8)