row_id,trial,nct,arm_label,role,device,include_core,budesonide_ug_ICS,formoterol_ug_LABA,glycopyrronium_ug_LAMA,dosing,duration_wk,population_note,n_randomized,n_mitt_exac,n_fev1,fev1_metric,fev1_window,fev1_lsmean_change_mL,fev1_se_mL,fev1_ci_low_mL,fev1_ci_high_mL,fev1_sd_mL,exac_definition,exac_events,exac_patient_years,exac_rate_annual,exac_rate_ci_low,exac_rate_ci_high,exac_pts_with_ge1,exac_n_analyzed,age_mean,male_pct,fev1_base_mL,fev1_base_pct_pred,eos_mean_cells_uL,eos_ge300_pct,exac_hist_mean_prioryr,current_smoker_pct,source_fev1,source_exac,source_baseline,source_table_fig,extractor,extract_date,notes
1,ETHOS,NCT02465567,BGF 320/18/9.6,Triple ICS/LAMA/LABA (high ICS),Aerosphere MDI,1,320,9.6,18,BID,52,Moderate-very severe COPD; >=1 mod/sev exacerbation in prior year; randomized 1:1:1:1; eosinophil-stratified,,,,LS mean change from baseline in morning trough FEV1 (mL),Week 24 (4-h PFT sub-study population),,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,ICS dose = HIGH. FEV1 N differs from exac mITT (sub-study).
2,ETHOS,NCT02465567,BGF 160/18/9.6,Triple ICS/LAMA/LABA (low ICS),Aerosphere MDI,1,160,9.6,18,BID,52,Moderate-very severe COPD; >=1 mod/sev exacerbation in prior year; randomized 1:1:1:1; eosinophil-stratified,,,,LS mean change from baseline in morning trough FEV1 (mL),Week 24 (4-h PFT sub-study population),,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,ICS dose = LOW. This is the within-triple ICS dose contrast vs BGF 320.
3,ETHOS,NCT02465567,GFF 18/9.6,Dual LAMA/LABA (no ICS),Aerosphere MDI,1,0,9.6,18,BID,52,Moderate-very severe COPD; >=1 mod/sev exacerbation in prior year; randomized 1:1:1:1; eosinophil-stratified,,,,LS mean change from baseline in morning trough FEV1 (mL),Week 24 (4-h PFT sub-study population),,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,No ICS component (dose 0).
4,ETHOS,NCT02465567,BFF 320/9.6,Dual ICS/LABA (no LAMA),Aerosphere MDI,1,320,9.6,0,BID,52,Moderate-very severe COPD; >=1 mod/sev exacerbation in prior year; randomized 1:1:1:1; eosinophil-stratified,,,,LS mean change from baseline in morning trough FEV1 (mL),Week 24 (4-h PFT sub-study population),,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,No LAMA component (dose 0).
5,KRONOS,NCT02497001,BGF 320/18/9.6,Triple ICS/LAMA/LABA,Aerosphere MDI,1,320,9.6,18,BID,24,Moderate-very severe COPD; NO prior-exacerbation requirement (>=0); randomized 2:2:1:1,,,,LS mean change from baseline in morning pre-dose trough FEV1 (mL),Over Weeks 12-24,,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,Same molecules/doses as ETHOS BGF 320 (commensurable).
6,KRONOS,NCT02497001,GFF 18/9.6,Dual LAMA/LABA (no ICS),Aerosphere MDI,1,0,9.6,18,BID,24,Moderate-very severe COPD; NO prior-exacerbation requirement (>=0); randomized 2:2:1:1,,,,LS mean change from baseline in morning pre-dose trough FEV1 (mL),Over Weeks 12-24,,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,No ICS component (dose 0).
7,KRONOS,NCT02497001,BFF 320/9.6,Dual ICS/LABA (no LAMA),Aerosphere MDI,1,320,9.6,0,BID,24,Moderate-very severe COPD; NO prior-exacerbation requirement (>=0); randomized 2:2:1:1,,,,LS mean change from baseline in morning pre-dose trough FEV1 (mL),Over Weeks 12-24,,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,No LAMA component (dose 0).
8,KRONOS,NCT02497001,BUD/FORM DPI 400/12,"Dual ICS/LABA (open-label, different device)",Turbuhaler DPI,0,400,12,0,BID,24,Moderate-very severe COPD; NO prior-exacerbation requirement (>=0); randomized 2:2:1:1,,,,LS mean change from baseline in morning pre-dose trough FEV1 (mL),Over Weeks 12-24,,,,,,"Moderate or severe COPD exacerbation (annualized rate, primary exacerbation outcome)",,,,,,,,,,,,,,,,,,,,,,"EXCLUDE from commensurable core (include_core=0): different device, budesonide 400 not 320, formoterol 12 not 9.6, open-label. Extract only if modeling a separate non-commensurable node."
