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Table 1 Incidence of adverse events (intent-to-treat (ITT)/safety population).

From: Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial

  Moxifloxacin
(N = 569)
n (%)
Placebo
(N = 580)
n (%)
p-value*
Any adverse event 467 (82.1) 493 (85.0) 0.181
Any treatment-emergent a adverse event 258 (45.3) 265 (45.7) 0.906
Any treatment-emergent a drug-related adverse events b 53 (9.3) 22 (3.8) < 0.001
   Cardiac disorders 3 (0.5) 1 (0.2)  
   Gastrointestinal disorders 27 (4.7) 4 (0.7)  
Diarrhea 17 (3.0) 9 (1.6)  
Nausea 6 (1.1) 0 (-)  
Vomiting 5 (0.9) 1 (0.2)  
   General disorders and administration site conditions 4 (0.7) 2 (0.3)  
Asthenia 3 (0.5) 0 (-)  
   Immune system disorders 4 (0.7) 0 (-)  
Hypersensitivity 3 (0.5) 0 (-)  
   Infections and infestations 5 (0.9) 3 (0.5)  
   Musculoskeletal and connective tissue disorders 3 (0.5) 1 (0.2)  
   Nervous system disorders 6 (1.1) 4 (0.7)  
Dizziness 3 (0.5) 1 (0.2)  
   Respiratory, thoracic and mediastinal disorders 8 (1.4) 0 (-)  
Dyspnea 4 (0.7) 0 (-)  
   Skin and subcutaneous tissue disorders 5 (0.9) 5 (0.9)  
   Deaths 15 (2.6) 17 (2.9)  
Any treatment-emergent a serious adverse event 94 (16.5) 97 (16.7) 0.926
Any treatment-emergent a drug-related serious adverse event 9 (1.6) 3 (0.3) 0.076
Any adverse event leading to premature discontinuation 26 (4.6) 16 (2.8) 0.102
Any deaths 19 (3.3) 26 (4.5) 0.318
  1. aEvents were determined to be treatment-emergent if they started after initiation of study medication up to 7 days post-therapy for each pulse of study medication
  2. bIndividual events listed under treatment-emergent drug-related adverse events occurring in ≥ 0.5% of subjects in either treatment group
  3. *Post-hoc unadjusted Chi-squared test