Table 1

Variables considered for the initial cluster analysis

Demography and medical historyAge (years)
Body mass index (kg/m2)
Pneumococcal vaccination status (baseline)
Influenza vaccination status (baseline)
COPD and exacerbation historyDuration of COPD, bronchitis/emphysema, moderate and severe exacerbation variables at baseline, smoking status/history
Outcome data: mean annual moderate/severe exacerbation data to reproduce primary end point modelling
Concomitant medication assessmentMedications at run-in/prior medications (including ATC codes and flags to identify prior period if needed)
Outcome/efficacy assessmentsAnnual rate of moderate/severe COPD exacerbations as defined in the two clinical trials. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; severe: worsening symptoms of COPD that required treatment with in-patient hospitalisation
Screening and baseline spirometryPre-bronchodilator FEV1 (L)
Post-bronchodilator FEV1 (L)
Per cent predicted post-bronchodilator FEV1 (%)
Post-bronchodilator FEV1/FVC (%)
Per cent reversibility FEV1 (%)
FEV1 reversibility (mL)
Reversibility at screening
Baseline FEV1 (L)
Physical examinationScreening/baseline medical conditions page: (body system level yes/no) with exception of cardiac disorders where each condition is listed explicitly from screening/baseline medical conditions page:
  • Cardiac disorders: congestive heart failure, coronary disease, myocardial infarction and arrhythmia

  • Eye disorders

  • Metabolism and nutrition disorders

  • Vascular disorders

  • Infections and infestations: pneumonia

  • Endocrine disorders

Laboratory assessments/ECGBaseline lymphocytes, WBC, eosinophils, neutrophils, BUN/urea, RBC, haemoglobin, ECG (p-wave dispersion)
  • ATC, anatomical therapeutic chemical; BUN, blood urea nitrogen; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; RBC, red blood cells; WBC, white blood cell counts.