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Table 5 Number of patients with adverse events on placebo and different daily doses of rostafuroxin

From: Main results of the Ouabain and Adducin for Specific Intervention on Sodium in Hypertension Trial (OASIS-HT): a randomized placebo-controlled phase-2 dose-finding study of rostafuroxin

 

Placebo

Rostafuroxin

 

All

All

0.05 mg

0.15 mg

0.5 mg

1.5 mg

5.0 mg

Total number of patients

419*

419†

84

84

81

87

83

Number with complaints

       

Osteomuscular‡

4

3

1

1

0

0

1

Gastro-intestinal#

5

5

0

1

1

1

2

Dizziness

2

5

0

1

0

4

0

Dry mouth

1

4

1

0

0

1

2

Headache

8

14

3

4

2

2

3

High blood pressure

4

6

1

3

2

0

0

Otitis

1

2

0

1

1

0

0

Palpitations

1

3

0

0

1

0

2

Cutaneous§

0

4

2

1

0

1

0

Upper respiratory tract infections

5

8

5

1

0

0

2

Urinary abnormalities¶

0

5

2

0

2

1

0

Urinary tract infections

2

5

1

2

0

2

0

  1. Values are number of subjects.
  2. *16 subjects did not receive placebo, because they withdrew from the trial in the first treatment period, while on rostafuroxin.
  3. †16 subjects did not receive rostafuroxin, because they withdrew from the trial in the first treatment period, while on placebo.
  4. ‡Bursitis or pain in back, neck, knees, or shoulders
  5. #Distension, abdominal pain, dyspepsia, gastritis, gastroenteritis or nausea.
  6. §Skin irritation, rash or dermatitis.
  7. ¶Proteinuria, glucosuria, or hematuria on semiquantitative dipstick test.