Table 1

Variables considered for the initial cluster analysis

	Variables
Demography and medical history	Age (years) Sex Race Ethnicity Body mass index (kg/m²) Pneumococcal vaccination status (baseline) Influenza vaccination status (baseline)
COPD and exacerbation history	Duration 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 assessment	Medications at run-in/prior medications (including ATC codes and flags to identify prior period if needed)
Outcome/efficacy assessments	Annual 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 spirometry	Pre-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 examination	Screening/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/ECG	Baseline 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.