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Table 5 Adverse events occurring in at least 5% of patients in either treatment group

From: An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome

 

pAT (N = 113)

AT gamma (N = 108)

Number of patients (%)

Number of events

Number of patients (%)

Number of events

Erythema

12 (10.6)

14

18 (16.7)

19

Diarrhea

6 (5.3)

6

17 (15.7)

18

Decubitus ulcer

10 (8.8)

12

12 (11.1)

13

Pneumonia

6 (5.3)

6

10 (9.3)

10

Vomiting

7 (6.2)

8

9 (8.3)

11

Constipation

4 (3.5)

5

9 (8.3)

9

Insomnia

10 (8.8)

10

9 (8.3)

9

Anemia

8 (7.1)

9

7 (6.5)

7

Sepsis

8 (7.1)

8

6 (5.6)

6

Hypokalemia

9 (8.0)

9

5 (4.6)

7

Hypernatremia

6 (5.3)

6

4 (3.7)

4

Pleural effusion

8 (7.1)

8

4 (3.7)

4

Nausea

7 (6.2)

7

3 (2.8)

4

Hepatic function abnormal

6 (5.3)

6

3 (2.8)

3

Blood bilirubin increased

6 (5.3)

6

3 (2.8)

3

Delirium

6 (5.3)

6

3 (2.8)

3

Skin exfoliation

11 (9.7)

17

3 (2.8)

3

  1. pAT plasma-derived antithrombin