Bruix 2012.
Study characteristics | ||
Methods | Randomised clinical trial. | |
Participants | Country: multi‐centric, international. Number randomised: 105. Post‐randomisation dropouts: 0 (0%). Revised sample size: 105. Mean age: 69 years. Females: 16 (15.2%). Cirrhosis: not stated. Portal hypertension: not stated. Viral aetiology: 39 (37.1%). Immunotherapy/antiviral adjuvant therapy: not stated. Mean follow‐up period (for all groups): not stated. Criteria for intermediate‐stage HCC and other inclusion criteria:
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Interventions | Participants were randomly assigned to 2 groups. Group 1: sorafenib (n = 54). Further details: chemotherapy: sorafenib 400 mg twice daily until radiological or symptomatic progression. Group 2: placebo (n = 51). |
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Outcomes | Mortality. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Study randomization was centralized, and assignment to study groups was conducted by computer to achieve a balance between the two groups". |
Allocation concealment (selection bias) | Low risk | Quote: "Study randomization was centralized, and assignment to study groups was conducted by computer to achieve a balance between the two groups". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "phase 3, double‐blind, placebo‐controlled trial…All eligible patients were randomly assigned in a 1:1 ratio to receive continuous oral treatment with either 400 mg of sorafenib (consisting of two 200‐mg tablets) twice daily or matching placebo". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "phase 3, double‐blind, placebo‐controlled trial…All eligible patients were randomly assigned in a 1:1 ratio to receive continuous oral treatment with either 400 mg of sorafenib (consisting of two 200‐mg tablets) twice daily or matching placebo". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were no post‐randomisation dropouts. |
Selective reporting (reporting bias) | High risk | Comment: morbidity was not reported. |
For‐profit bias | High risk | Quote: "The study was designed by Bayer HealthCare Pharmaceuticals in conjunction with the principal academic investigators". |
Other bias | Low risk | Comment: no other bias noted. |