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Table 3 Safety results

From: Alkaline phosphatase for treatment of sepsis-induced acute kidney injury: a prospective randomized double-blind placebo-controlled trial

  

AP

Placebo

All adverse events (AEs)

n (%)

130 (100)

154 (100)

Treatment-emergent AEs*

n (%)

124 (95)

147 (96)

Patients with treatment-emergent AEs

n (%)

15/16 (94)

20/20 (100)

Non-serious treatment-emergent AEsa:

n

  

Atrial fibrillation

 

3

6

Diarrhea

 

6

3

Hypotension

 

2

7

Delirium

 

2

5

Decubitus ulcer

 

1

4

Abdominal pain

 

3

2

Pyrexia

 

1

4

Impaired gastric emptying

 

3

2

Tracheostomy

 

1

3

Constipation

 

1

3

Restlessness

 

2

2

Atrial flutter

 

1

3

All serious treatment-emergent AEs

n

  

Septic shock

 

2

2

Respiratory failure

 

3

1

Gastrointestinal necrosis

 

2

.

Hypotension

 

.

2

Hepatic necrosis

 

1

.

Gall bladder necrosis

 

1

.

Electrolyte imbalance

 

1

.

Azotemia

 

1

.

Cardiac arrest

 

.

1

Bradycardia

 

.

1

Electrocardiogram QT prolonged

 

.

1

Blood calcium decreased

 

.

1

Coma

 

.

1

Hyperlactacidemia

 

.

1

Depressed level of consciousness

 

.

1

Osteomyelitis

 

1

.

Brain neoplasm

 

.

1

Renal failure

 

.

1

Therapy cessation

 

1

.

Echocardiogram abnormal

 

1

.

  1. AP, alkaline phosphatase.
  2. *There were no treatment differences between the study groups regarding the number of Treatment-emergent AEs per patient (Fisher's exact test: P = 0.9089).
  3. a: > 4 reported events in total.
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