Table 3 MUK eight secondary and exploratory endpoint analysis

S(i) Proportion of patients achieving at least Partial Response

[D1] Logistic regression

S(ii) Proportion of patients in each maximum response category

[D1] Ordered logistic regression

S(iii) Time to progression

[D1] CIF and log-rank test, Cox PH

S(iv) Time to maximum response

[D1] Kaplan-Meier and log-rank test, Cox PH, CIF

S(v) Duration of response

[D1] Kaplan-Meier and log-rank test, Cox PH

S(vi) Overall survival

[D1] Kaplan-Meier and log-rank test, Cox PH

S(viii) Treatment compliance

[NFT] Descriptive summaries

S(ix) Safety and toxicity

[NFT] Descriptive summaries

S(x) Cost-effectiveness

[HE] Cost-utility analysis, cost effectiveness acceptability curves

S(xi) Quality of life

[D1] Multi-level repeated measures model

E(i) To identify possible biomarkers of response to ICD

[NFT] Descriptive summaries

E(ii) To estimate PFS2 for those that switch to ICD following CD treatment

[NFT] Kaplan-Meier and [D2] exploratory analyses: Kaplan-Meier and log-rank test, Cox PH

E(iii) To estimate PFS Switch for those that switch to ICD following CD treatment

[NFT] Kaplan-Meier and [D3] exploratory analyses of the ratio of PFS from switch against PFS on CD pre-switch

E(iv) Proportion of patients achieving at least Partial Response for ICD following CD treatment

[NFT] Descriptive summaries

E(v) Proportion of patients in each maximum response category of ICD following CD treatment

[NFT] Descriptive summaries

E(vi) Time to maximum response for ICD following CD treatment

[NFT] Kaplan-Meier

E(vii) Duration of response for ICD following CD treatment

[NFT] Kaplan-Meier

E(viii) Treatment compliance for ICD following CD treatment

[NFT] Descriptive summaries

E(ix) Safety and toxicity for ICD following CD treatment

[NFT] Descriptive summaries