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Table 2 Pooled analysis of AEs extracted from the studies on erdosteine, carbocysteine, and NAC in COPD patients and ranked by frequency in agreement with EMA guidelines [37]

From: Efficacy and safety profile of mucolytic/antioxidant agents in chronic obstructive pulmonary disease: a comparative analysis across erdosteine, carbocysteine, and N-acetylcysteine

 

Erdosteine

Carbocysteine

NAC

Placebo

Total number of subjects

354

557

553

1151

Frequency (%) of all AEs

1.32 (+++)

2.26 (+++)

18.26 (++++)

8.43 (+++)

Frequency (%) of specific AEs:

 respiratory tract infection

ND

0.56 (+++)

10.85 (++++)

4.26 (+++)

 gastrointestinal disorders

0.44 (++)

1.13 (+++)

4.16 (+++)

4.26 (+++)

 pruritus

ND

ND

1.08 (+++)

2.69 (+++)

 cerebrovascular disorders

0.44 (++)

ND

0.90 (++)

0.09 (+)

 dizziness

ND

ND

0.72 (++)

0.09 (+)

 musculoskeletal disorders

ND

0.28 (++)

0.54 (++)

0.78 (++)

 hepatobiliary disorders

0.44 (++)

ND

ND

ND

 malaise

ND

0.28 (++)

ND

0.09 (+)

 insomnia

ND

ND

ND

0.26 (++)

 increased cough

ND

ND

ND

0.17 (++)

  1. ++++: very common (≥1/10); +++: common (≥1/100 to < 1/10); ++: uncommon (≥1/1000 to < 1/100); +: rare (≥1/10,000 to < 1/1000); AEs: adverse events; COPD: chronic obstructive pulmonary disease; EMA: European Medicine Agency; NAC: N-acetylcysteine; ND: not detectable (frequency not known)