TABLE 4

Adverse events in the AMAZES severe asthma subset

Placebo (N=96)Azithromycin (N=115)
Serious adverse events15/13 (13.5%)22/14 (12.2%)
 Cardiac1/1 (1.0%)2/2 (1.7%)
 Gastrointestinal tract4/3 (3.1%)4/4 (3.5%)
 Other health issue5/4 (4.2%)9/3 (2.6%)
 Possible infectious serious adverse event5/5 (5.2%)5/3 (2.6%)
 Events per person
  No events83 (86.5%)101 (87.8%)
  1 event12 (12.5%)10 (8.7%)
  2 events01 (0.9%)
  3 events1 (1.0%)2 (1.7%)
  4 events01 (0.9%)
 Study withdrawal (treatment discontinuation due to adverse event)7 (7.3%)7 (6.1%)
Treatment-related adverse events
 Nausea6 (6.3%)21 (18.3%)
 Diarrhoea22 (22.9%)41 (35.7%)
 Abdominal pain16 (16.7%)24 (20.9%)
 Other gastrointestinal2 (2.1%)5 (4.4%)
 Headache2 (2.1%)3 (2.6%)
 Vertigo01 (0.9%)
 Tinnitus1 (1.0%)0
 Hearing loss4 (10.5%)4 (6.8%)
 High liver function tests results2 (2.1%)1 (0.9%)
 Oral thrush1 (1.0%)4 (3.5%)
 Allergy01 (0.9%)
 Rash7 (7.3%)4 (3.5%)
 QTc prolongation1 (2.6%)3 (5.1%)
 Other adverse event17 (17.7%)22 (19.1%)

Data are presented as n events/n (%) people, unless otherwise stated. QTc: corrected QT interval.