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Table 2 Rate of adverse events reported in RCT and non-randomised studies

From: Clinical effectiveness and cost-effectiveness of pegvisomant for the treatment of acromegaly: a systematic review and economic evaluation

Adverse event

Trainer 2000[7]

Placebo

n = 32

Trainer 2000[7]

PEG 10mg/d

n = 26

Trainer 2000[7]

PEG 15mg/d

n = 26

Trainer 2000[7]

PEG 20mg/d

n = 28

¶ †Open label

van der Lely (2001)[8]

PEG

n = 160

¶¶ ††Open label Scheiber (2007)[21]

PEG

n = 229

†††Open label Jehle (2005)[17]

PEG

n = 10

Infections

5* (16%)

5* (19%)

4* (15%)

5* (18%)

52 (33%)

 

1 (10%)

Headache

4 (12%)

3 (12%)

2 (8%)

3 (11%)

41 (26%)

4 (1.7%)

3 (30%)

Injection-site reaction

0 (0%)

2 (8%)

1 (4%)

3 (11%)

18 (11%)

17 (7.4%)

--

Pain

2 (6%)

2 (8%)

1 (4%)

4 (14%)

36 (23%)

--

--

Diarrhoea

1 (3%)

1 (4%)

0 (0%)

4 (14%)

23 (14%)

--

--

Nausea

1 (3%)

0 (0%)

2 (8%)

4 (14%)

--

--

--

Flatulence

0 (0%)

0 (0%)

1 (4%)

3 (11%)

--

--

-v

Influenza-like syndrome

--

--

--

--

33 (21%)

--

--

Accidental injury

--

--

--

--

28 (18%)

--

--

Hypercholesterolemia

--

--

--

--

23 (14%)

--

--

Back pain

--

--

--

--

21 (13%)

--

--

Asthenia

--

--

--

--

21 (13%)

--

--

Arthralgia

--

--

--

--

19 (12%)

--

--

Sinusitis

--

--

--

--

16 (10%)

--

--

Insomnia (transient)

--

--

--

--

--

--

2 (20%)

Fatigue

--

--

--

--

--

--

3 (30%)

  1. ¶Number of patients (%) with adverse events that occurred in at least 10% of patients.
  2. ¶P Number of patients (%) with adverse events occurring in > 1% and judged potentially causally related to PEG treatment.
  3. † mean follow up 61 weeks. †† maximum follow up 102 weeks. ††† follow up 10 to 20 months. * upper respiratory tract infection only.