Table 2.

SAE/withdrawal/exclusion

ITT/PP	Allocation [duration]	SAE/withdrawal/exclusion	Outcome
ITT	Placebo [0 h]	Recovery with extubation before trial drug administration (incl. criteria not met). Excluded	Death on day 13 (resp. failure)
ITT	Placebo [14 h]	Thrombosis in the arterial cannula (difficult insertion in Aa. radialis, instead US-guided insertion in a. brachialis). SAE/withdrawal	LMWH treatment (10.000 IE) with good effect. Survivor
ITT	Placebo [14 h]	Indication for Flolan inhalation (severe respiratory failure). SAE/withdrawal	Death on day 2 (respiratory failure)
PP	Placebo [completed]	Iatrogenic pneumothorax and intraabdominal bleeding after liver abscess drainage, 28 h after ceasing trial drug. SAE	Death on day 2 (pneumonia)
ITT	Active [0 h]	Indication for acute abdominal surgery before trial drug administration. Excluded	Survivor
ITT	Active [21 h]	Indication for therapeutic LMWH (suspicion of type II MI). Cardiac enzymes elevated before inclusion, but increasing. SAE/withdrawal	Death on day 10 (cardiac failure)
ITT	Active [28 h]	Transferred to other ICU due to overcrowding. Withdrawal	Survivor
PP	Active [complete]	Severe septic shock (Capnocytophagus carnimorsus) with bradycardia treated with 1 mg adrenalin IV and 2 min CPR. Circulatory stabilised after 2 min. Transferred to tertiary ICU day 4. Necrotomy of the face and leg day 27. Finger amputation (1., 2., 4., 5. finger on the left hand) day 35. Femur amputation day 50. SAE	Survivor

ITT intention to treat, PP per protocol, SAE serious adverse event, US ultrasound, LMWH low molecular weight heparin, MI myocardial infarction, ICU intensive care unit, IV intravenous, CPR cardiopulmonary resuscitation