Skip to main content

Table 5 Most common 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 TEAE 8 (100.0) 9 (100.0) 12 (100.0) 8 (80.0) 7 (87.5) 23 (100.0)
Anemia 1 (12.5) 3 (33.3) 2 (16.7) 1 (10.0) 2 (25.0) 4 (17.4)
Agitation 2 (25.0) 2 (22.2) 1 (8.3) 3 (30.0) 1 (12.5) 4 (17.4)
Constipation 2 (25.0) 2 (22.2) 2 (16.7) 1 (10.0) 0 6 (26.1)
Generalized edema 0 1 (11.1) 3 (25.0) 2 (20.0) 3 (37.5) 3 (13.0)
Hypoglycemia 1 (12.5) 1 (11.1) 1 (8.3) 4 (40.0) 3 (37.5) 2 (8.7)
Hypokalemia 2 (25.0) 1 (11.1) 0 2 (20.0) 0 7 (30.4)
Hypernatremia 1 (12.5) 1 (11.1) 0 3 (30.0) 2 (25.0) 2 (8.7)
Hypophosphatemia 2 (25.0) 1 (11.1) 0 2 (20.0) 1 (12.5) 2 (8.7)
Diarrhea 2 (25.0) 0 0 1 (10.0) 1 (12.5) 4 (17.4)
Edema peripheral 2 (25.0) 0 0 0 1 (12.5) 4 (17.4)
Insomnia 1 (12.5) 2 (22.2) 0 1 (10.0) 0 2 (8.7)
Sepsis 1 (12.5) 0 3 (25.0) 0 0 1 (4.3)
Wheezing 1 (12.5) 2 (22.2) 0 1 (10.0) 0 1 (4.3)
Bradycardia 0 0 0 2 (20.0) 0 3 (13.0)
Feeding disorder 1 (12.5) 2 (22.2) 0 0 0 1 (4.3)
Decubitus ulcer 1 (12.5) 0 0 2 (20.0) 1 (12.5) 0
Hypertension 0 1 (11.1) 0 2 (20.0) 1 (12.5) 0
Scleral hemorrhage 2 (25.0) 0 0 0 0 0
  1. *Data arranged in order of overall frequency (≥ 20% in any cohort)