Secondary endpoint | Main comparison(s) | Analysis method(s) |
---|---|---|
Key secondary: proportion of participants experiencing ≥ grade 3 neuropathy or ≥ grade 2 neuropathy with pain during initial treatment | (a) vs. (b) | [S] Logistic regression |
(i) Total time spent at each grade of toxicity for ≥ grade 3 neuropathy or ≥ grade 2 neuropathy with pain during initial treatment | (a) vs. (b) | [NFT] Descriptive summaries |
(ii) Complete response rate 24 weeks post initial randomisation | (a) vs. (b) | [NI] Logistic regression |
(iii) Overall response rate 24 weeks post initial randomisation | (a) vs. (b) | [NI] Logistic regression |
(iv) Proportion of participants achieving MRD negative disease at the end of initial treatment | (a) vs. (b) | [NI] Logistic regression |
(v) MRD status of participants at 6 and 12 months following second randomisation and alteration in MRD status | (c) vs. (d) | [S] Logistic regression |
(vi) PFS by MRD status at the end of initial treatment | MRD -ve vs. MRD + ve | [S] Kaplan-Meier & log-rank test, Cox PH |
(vii) Overall response rate within 12 months of initial randomisation | (c) vs. (d), (a) vs. (e) | [S] Logistic regression |
(viii) Maximum response within 12 months of initial randomisation | (c) vs. (d), (a) vs. (e) | [NFT] Descriptive summaries |
(ix) Maximum response overall | (c) vs. (d), (a) vs. (e) | [NFT] Descriptive summaries |
(x) Time to maximum response | (c) vs. (d), (a) vs. (e) | [S] Kaplan-Meier & log-rank test, Cox PH |
(xi) Duration of response | (c) vs. (d), (a) vs. (e) | [S] Kaplan-Meier & log-rank test, Cox PH |
(xii) Overall survival | (c) vs. (d), (a) vs. (e) | [S] Kaplan-Meier & log-rank test, Cox PH |
(xiii) Time to next treatment | (c) vs. (d), (a) vs. (e) | [NFT] Kaplan-Meier; Cumulative Incidence Functions (competing risks) |
(xiv) Toxicity overall, and per cycle of treatment (initial and maintenance treatment) | (a) vs. (b), (c) vs. (d) | [NFT] Descriptive summaries, graded by Common Terminology Criteria for Adverse Events V4.0 |
(xv) Treatment compliance | (a) vs. (b), (c) vs. (d) | [NFT] Descriptive summaries |
(xvi) Safety | (a) vs. (b), (c) vs. (d) | [NFT] Descriptive summaries |