Fujisawa 1996.
Study characteristics | ||
Methods | Japanese RCT | |
Participants |
Number of participants: 82 (between 1986 and 1990) Number randomised
Number evaluated
Diagnosis: patients with NSCLC who had undergone a complete resection and mediastinal lymph node dissection Inclusion: the eligibility criteria was:
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Interventions |
Experimental group: TF and N‐CWS: 1 vial of TF, equivalent to 5 x 10⁸ peripheral lymphocytes, was administered subcutaneously every 4 weeks, and N‐CWS (200 mg) was administered subcutaneously every 2 weeks, beginning 1 month after resections, and continuing for 1 year Control group: participants received surgery alone without any particular treatment until recurrence |
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Outcomes | Duration of follow‐up (median): experimental group: 99 months, control group: 83 months
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Notes | Supported in part by grants‐in‐aid for scientific research 05453481 from the Ministry of Education and Culture of Japan | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | The author reported "Patients were randomised into two groups, TF + N‐CWS or control, by closed envelope", without detailed information about how the envelope was generated and kept. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 82 randomised participants were included in analysis (100%) |
Selective reporting (reporting bias) | High risk | Prior protocol was unavailable, and no prespecified primary outcome was reported |
Other bias | Low risk | No obvious potential source of bias |