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Table 6 Serious treatment-emergent adverse events, irrespective of relationship to study drug (safety population)*

From: A placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of single and multiple intravenous infusions of AZD9773 in patients with severe sepsis and septic shock

  AZD9773 cohort 1
(50 U/kg)
(n= 8)
AZD9773 cohort 2
(250 U/kg)
(n= 9)
AZD9773 cohort 3
(250/50 U/kg) (n= 12)
AZD9773 cohort 4
(500/100 U/kg) (n= 10)
AZD9773 cohort 5
(750/250 U/kg)
(n= 8)
Placebo
(n= 23)
Patients with any serious TEAE 3 (37.5) 6 (66.7) 7 (58.3) 3 (30.0) 4 (50.0) 13 (56.5)
Sepsis 1 (12.5) 0 3 (25.0) 0 0 1 (4.3)
Pneumonia 1 (12.5) 1 (11.1) 0 0 0 2 (8.7)
Septic shock 0 1 (11.1) 0 0 1 (12.5) 2 (8.7)
Respiratory failure 0 0 0 2 (20.0) 0 2 (8.7)
Cardiac arrest 1 (12.5) 1 (11.1) 0 0 0 1 (4.3)
Pulmonary embolism 0 1 (11.1) 0 0 1 (12.5) 1 (4.3)
Deep vein thrombosis 0 0 1 (8.3) 1 (10.0) 0 1 (4.3)
Hemorrhagic shock 0 0 1 (8.3) 0 0 1 (4.3)
Empyema 0 0 1 (8.3) 0 0 0
Endocarditis 0 1 (11.1) 0 0 0 0
Cellulitis 0 0 0 0 0 1 (4.3)
Acute myocardial infarction 0 0 0 1 (10.0) 0 0
Cardiac failure 0 0 1 (8.3) 0 0 0
Supraventricular tachycardia 0 0 0 1 (10.0) 0 0
Atrial fibrillation 0 0 0 0 0 1 (4.3)
Pneumonia aspiration 0 0 0 1 (10.0) 0 0
Hypoxia 0 0 0 0 0 1 (4.3)
Shock 0 0 1 (8.3) 0 0 0
Peripheral ischemia 0 0 0 0 0 1 (4.3)
Enterocutaneous fistula 0 0 0 0 1 (12.5) 0
Intestinal ischemia 0 0 0 0 1 (12.5) 0
Intestinal perforation 0 0 0 0 0 1 (4.3)
Medical device complication 0 1 (11.1) 0 0 0 0
Acidosis 0 1 (11.1) 0 0 0 0
Malignant lung neoplasm 0 1 (11.1) 0 0 0 0
Cerebral infarction 0 0 1 (8.3) 0 0 0
Intracranial hemorrhage 0 0 0 0 0 1 (4.3)
Toxic epidermal necrolysis 1 (12.5) 0 0 0 0 0
Muscle hemorrhage 0 0 0 0 0 1 (4.3)
  1. *Data arranged in order of overall frequency