Weller 2017.
Study characteristics | ||
Methods | Phase III randomised, double‐blind | |
Participants | First‐line glioblastoma patient: randomisation (1:1) ‐ 195 rindopepimut and temozolomide, 210 standard of care (temozolomide) | |
Interventions | Rindopepimut + temozolomide vs temozolomide | |
Outcomes |
|
|
Notes | Terminated early at second preplanned interim analysis – futility boundary crossed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random assignment to treatment groups with a prespecified randomisation sequence with a block size of 4. |
Allocation concealment (selection bias) | Low risk | Double‐blinded study – unblinded pharmacists obtained randomly assigned treatment assignments and managed study treatment via interactive response technology |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded study Placebo vaccine ‐ preloaded with immunostimulant |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Local assessors (blinded), central assessors (also blinded for PFS and ORR assessments) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Unclear risk | None |
Other bias | Low risk |