Whittaker 2012.

Study characteristics
Methods	This was a randomised, open‐label, multicentre study which lasted 16 weeks.
Participants	This study recruited 93 patients with mycosis fungoides stage IB to IIA, who were randomised to receive bexarotene in combination with PUVA vs. PUVA alone. A histologically‐confirmed mycosis fungoides stage IB or IIA, confirmed by current or prior diagnostic lesion biopsy, was required to enrol in this study. Demographics of the included participants Sex:majority male, absolute numbers not reported, according to authors "evenly distributed" Age: Mean age (range) not reported Stages of disease: IB‐IIA (distribution not reported) 1 of 45 participants (2%) was lost to follow‐up in the PUVA; intention to treat analysis carried out Exclusion criteria of the trial Any topical therapy within 4 weeks prior to the study
Interventions	Arm I: participants receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week. Arm II: participants receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity.
Outcomes	Primary outcomes of the trial Overall response rate (complete clinical response (CCR) and partial response (PR)) Secondary outcomes of the trial Cumulative dose of UVA required to achieve CCR Number of PUVA sessions necessary to achieve a CCR Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression Time‐to‐relapse Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment
Notes	This study was funded by educational grants from Ligand Pharmaceuticals Inc./Eisai Co., Ltd. and by a donation from Cancer Research U.K. through the EORTC Charitable Trust. The authors stated no conflicts of interest. This study was conducted in tertiary care hospitals in 11 participating countries.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The authors used a minimisation method for randomising patients into treatment arms.
Allocation concealment (selection bias)	Unclear risk	The study did not provide information about this. We sought information but got no response. We judged this to be of unclear risk.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study personnel were not blinded to study groups.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	This was unknown. We contacted the corresponding author for additional outcome data, but we received no reply within 4 weeks.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was carried out. 6 of 93 patients did not start treatment after randomisation. For 5 of those 6, reasons for not starting therapy were not stated. The other patient was ineligible because of prior treatment. Additionally 1 patient lost to follow‐up and 1 drop out for "other" reasons.
Selective reporting (reporting bias)	Low risk	Although the primary outcome measure was changed during the conduct of the trial, the authors clearly stated the reason for this change (low accrual and overestimation of CR). The primary end point was changed from cumulative dose of UVA necessary to achieve a CR to cumulative dose of UVA to achieve an ORR.
Other bias	High risk	The primary end point was changed after realising that the a priori expected rate of complete responses was overestimated in trial design.