Sederholm 2005.
Methods | Randomized multi‐center phase III trial Eligible patients
Exclusion criteria
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Participants | G arm: 170 participants (ITT population)/34 elderly participants GC arm: 164 participants (ITT population)/41 elderly participants |
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Interventions | G arm: gemcitabine 1250 mg/m2 over 30 to 60‐minute i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles, unless disease progression or intolerable toxicity. GC arm: carboplatin AUC5 over 30 to 60‐minute i.v. infusion on day 1 and gemcitabine 1250 mg/m2 over 30 to 60‐minute i.v. infusion on days 1 and 8, every 3 weeks |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | No information on subgroup analysis of elderly participants, despite multiple attempts to contact study authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned to receive either..." |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome | Unclear risk | No information on blinding |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | Study designed for general population; elderly subgroup analysis not planned |