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. 2019 Apr 23;20:136. doi: 10.1186/s12882-019-1290-5

Table 2.

Model inputs modified in sensitivity and scenario analyses

Modified variables Modified inputs
Sensitivity analysis
 Discontinuation of treatmenta,b 15.30, 6.51, 2.89 and 0.50% in years 1, 2, 3 and 4+, respectively
 Replication of ADPKD progression observed in TEMPO 3:4a Percentage change in TKV from baseline with placebo: 5.05, 11.49 and 18.85% in years 1, 2 and 3, respectively
Annual eGFR slope (mL/min/1. 73m2):
− 3.812 with placebo
− 2.609 with tolvaptan
 Treatment effect based on CKD-Epi equationa 26.4% reduction in eGFR decline
Scenario analysis
 Treatment effect by CKD stage at tolvaptan initiationa CKD 1 14.7% reduction in eGFR decline
CKD 2 31.0% reduction in eGFR decline
CKD 3 40.5% reduction in eGFR decline
 Treatment effect based on CKD-Epi equation CKD stage at tolvaptan initiationc CKD 1 15.5% reduction in eGFR decline
CKD 2 29.1% reduction in eGFR decline
CKD 3 31.0% reduction in eGFR decline
Mayo imaging classification at tolvaptan initiationd 1C-1E 28.2% reduction in eGFR decline

CKD Chronic kidney disease, CKD-Epi Chronic Kidney Disease Epidemiology Collaboration, eGFR estimated glomerular filtration rate, TKV total kidney volume

aObserved in TEMPO 3:4 [8, 34]

bRate extrapolated after year 3

cTreatment effects reported for CKD 1 to CKD 3 subgroups in TEMPO 3:4 [10]; eGFR was estimated using the CKD-Epi equation [14]

dTreatment effect (eGFR slope − 2.82 mL/min/1. 73 m2 for tolvaptan versus − 3.93 mL/min/1. 73 m2 in placebo) reported for Mayo subclass 1C-E patients in TEMPO 3:4 [35]; eGFR was estimated using the CKD-Epi equation [14]