Fujisawa 1996

Methods	Japanese RCT
Participants	Number of participants: 82 (Between 1986 and 1990) Number randomised: Experimental group (surgery + transfer factor (TF) + nocardia rubra‐cell wall skeleton (N‐CWS)): 41 Control group (surgery only): 41 Number evaluated: Experimental group: 41 Control group: 41 Diagnosis: Patients with non‐small cell lung carcinoma who had undergone a complete resection and mediastinal lymph node dissection. Inclusion: The eligibility criteria was as follows: non‐small cell carcinoma; pathologic Stage T1N0M0 or T2N0M0 disease; compIete resection; age younger than 75 years; Karnofsky performance status of 90% or greater; no other active malignancy; no hepatorenal dysfunction; no severe complications.
Interventions	Experimental group: Transfer factor (TF) and nocardia rubra‐cell wall skeleton (N‐CWS) One vial of TF, equivalent to 5 x 10⁸ peripheral lymphocytes, was administered subcutaneously (sc) every 4 weeks, and N‐CWS (200 mg) was administered sc 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.
Outcomes	Duration of follow‐up (median): experimental group: 99 months, control group: 83 months. Overall survival, disease‐specific survival, recurrence‐free survival
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 pre‐specified primary outcome was reported.
Other bias	Low risk	No obvious potential source of bias