Johnsson Nordic ACT 2013.
Methods | Phase III open‐label RCT; n = 249 | |
Participants | People with mCRC after finishing first‐line treatment with combined chemotherapy and bevacizumab | |
Interventions | Combined erlotinib and bevacizumab vs bevacizumab | |
Outcomes | Primary outcome: PFS. Secondary outcomes: OS, toxicity | |
Notes | Supported by Roche Sweden, Futurum ‐ the Academy for Healthcare, Jonkoping County Council, and by the Skane Regional Council. Johnsson: presentation honoraria from Genentech. Follow‐up 36.8 months |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised 1:1 ‐ no further information |
Allocation concealment (selection bias) | Unclear risk | No further information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No independent radiology review was done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcome reported when 131/159 participants progressed; 6 participants (4 interventional, 2 control arms) withdrawn due to aim for curative surgery. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | No other significant bias present; funders did not have inappropriate influence. |