Table 3. Description of adverse events in 21 enrolled patients.

Patient	Description	SAE	Day of onset (duration)	Severity	Relationship to study drug	Action taken with study drug	28-day Outcome
1	Femoral and iliac thrombosis	No	D1 –D3	Severe	Unrelated	No action	Alive
	Acute non-lithiasic cholecystitis	No	D1	Severe	Unrelated	No action	Alive
2	No adverse event						Alive
3	Bilateral pleural effusion	No	D1–D28	Mild	Unrelated	No action	Alive
	ICU-acquired septic shock	Yes	D8 –D15	Severe	Unrelated	No action	Alive
4	ICU-acquired septic shock	Yes	D20 –D23	Severe	Unrelated	No action	Alive
5	Supraventricular tachycardia	No	D1	Severe	Potential link	Discontinuation	Alive
6	Hypotension	Yes	D1	Severe	Potential link	Decrease Infusion rate	Alive
	Refractory septic shock	Yes	D14	Severe	Unrelated	No action	Death
7	Haemorrhoidal bleeding	No	D5	Severe	Unrelated	No action	Alive
	Oedema in the lower limbs	No	D-6 –D19	Moderate	Not determined	No action	Alive
8	No adverse event						Alive
9	Right pleural effusion	No	D4 –D28	Mild	Unrelated	No action	Alive
10	Leukopaenia–neutropaenia–thrombocytopaenia	Yes	D8 –D15	Mild	Potential link	No action	Alive
	Leukopaenia–neutropaenia–thrombocytopaenia	Yes	D22–D28	Mild	Potential link	No action	Alive
11	Diarrhea	Yes	D3 –D7	Mild	Unrelated	No action	Alive
	Oedema	Yes	D7–D28	Mild	Unrelated	No action	Alive
12	No adverse event						Alive
13	No adverse event						Alive
14	No adverse event						Alive
15	Digestive bleeding	Yes	D7	Mild	Unrelated	No action	Alive
	Respiratory distress	Yes	D12 –D14	Severe	Unrelated	Withholding	Death
16	No adverse event						Alive
17	Anaemia	No	D1	Mild	Unrelated	No action	Alive
	Tracheotomy	No	D4	Mild	Unrelated	No action	Alive
	Epistaxis	No	D5	Mild	Unrelated	No action	Alive
	Cardiac arrest	Yes	D7	Severe	Unrelated	No action	Death
18	No adverse event						Alive
19	Respiratory distress	Yes	D25	Severe	Unrelated	No action	Death
20	No adverse event						Alive
21	Septic shock	Yes	D1 –D5	Severe	Unrelated	No action	Alive
	Death	Yes	D9	Severe	Unrelated	Withholding	Death

Abbreviations: SAE, Serious Adverse Event; D, Day