| Study characteristics |
| Methods |
Phase II multicentre, randomised, placebo‐controlled |
| Participants |
Recurrent/progressive glioblastoma patients, 38 participants in total |
| Interventions |
Cediranib and gefitinib combination versus cediranib and placebo |
| Outcomes |
OS: 7.2 vs 5.5 months (HR 0.68, 90% CI 0.39 to 1.19) PFS: 3.6 vs 2.8 months (HR 0.72, 90% CI 0.41 to 1.26) PFS6: 15.8% vs 15.8% OS12: 15.8% vs 10.5% Toxicity: fatigue, hypertension, lymphopenia, anorexia, ataxia |
| Notes |
Cediranib discontinued by AstraZeneca – trial terminated early in August 2012. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation system was managed independent of the trial management team. Registration fax from the recruiting site trial staff would use an online randomisation system to produce container numbers for the assigned treatment. |
| Allocation concealment (selection bias) |
Low risk |
Contents of the bottles were concealed from site staff, participants, and trial management. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not mentioned, insufficient information (likely low risk) |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing information |
| Selective reporting (reporting bias) |
Low risk |
All prespecified endpoints reported. |
| Other bias |
Low risk |
Early termination of study due to cessation of cediranib production, decision made by manufacturer. |
