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Table 5 Treatment-emergent and treatment-related adverse events (AEs) (n = 30, safety population)

From: Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation

 

Formulation

Overall

 

A

B

C

 

Subjects experiencing a treatment-emergent AE, n (%)

19/30 (63.3)

16/29 (55.2)

18/29 (62.1)

26/30 (86.7)

Treatment-emergent AEs, n

35

27

29

91

Treatment-related AEs

    

Total, n

24

12

20

56

   Nausea

12

4

9

25

   Headache

2

4

5

11

   Dizziness

4

2

2

8

   Vomiting

2

0

1

3

   Upper abdominal pain

0

1

0

1

   Abdominal pain

1

0

0

1

   Peripheral oedema

1

0

0

1

   Abdominal discomfort

0

0

1

1

   Tachycardia

1

0

0

1

   Pain in extremity

1

0

0

1

   Asthenia

0

1

0

1

   Injection site bruising

0

0

1

1

   Tremor

0

0

1

1

  1. r-hGH, recombinant human growth hormone.
  2. A = r-hGH liquid multi-dose, 5.83 mg/mL.
  3. B = r-hGH liquid multi-dose, 8.0 mg/mL.
  4. C = r-hGH freeze-dried 8.8 mg, reconstituted in 1.51 mL.