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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)