*Modelled events have been aligned to the individual component endpoints of DAPA-CKD
Assumptions:
This information is based on a DAPA-CKD time to event (TTE) model intended to quantify and communicate the benefit in terms of delaying events associated with CKD associated with dapagliflozin and placebo in addition to SoC based on the results of the DAPA-CKD trial.
The model predicts the time-to event data for patients receiving treatment with dapagliflozin or placebo, based on observations from DAPA-CKD.
The model was developed as a closed cohort-level partitioned survival model (PSM), whereby patients reside in one of a series of exhaustive and mutually exclusive health states with time-dependent health state membership determined fully by a series of independently modelled non-mutually exclusive survival curves.
The incidence of outcomes can be adjusted for estimated all-
cause mortality based on the results of DAPA-CKD, such that the numbers of patients at risk of experiencing clinical outcomes will decrease over the modelled time horizon in line with the results observed in DAPA-CKD.
The model estimates outcomes over a variable time horizon of up to thirty years and has a monthly cycle length. Mean and incremental time to event estimates are derived from a lifetime perspective (e.g. the mean time to event may be more than the select time horizon).
Limitations:
One of the central limitations of the PSM approach is the key structural assumption that the survival functions for each of the health states are independent, which represents a significant limitation when extrapolating results.
Competing risks are not considered and mortality risks will be assumed to apply equally to all patients.
This model provides an estimate only of estimated events based on DAPA-CKD.
