NCT00719264.

Study characteristics
Methods	Study name: RECORD‐2 Study design: a two‐arm, RCT, phase II Blinding: none, open‐label Date of enrolment/randomisation: not reported Date of data cut‐off: December 31, 2011 (for PFS); August 30, 2012 (for OS and safety) Location: 21 countries (Belgium, Brazil, Czech Republic, Egypt, France, Germany, Hong Kong, Hungary, Italy, Republic of Korea, the Netherlands, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, USA.) types of centres: (108 study locations) Cross‐over study or cross over permitted: not per design; not reported whether cross over was permitted at some point (e.g. upon progression)
Participants	Inclusion criteria: all sexes 18 years and older participants with mRCC participants with progressive mRCC participants who had a prior partial or complete nephrectomy participants with a KPS ≥70% Exclusion criteria: 4 weeks post‐major surgery participants who had radiation therapy within 28 days prior to start of study participants in need for major surgical procedure during the course of the study participants who have received prior systemic treatment for their metastatic RCC participants who received prior therapy with VEGF pathway inhibitor Sample size: N=365 Age, Mean (years, SD): experimental arm: 60.71 (10.6) , control arm: 59.9 (10.3) Sex, m/f): experimental arm: 138/44, control arm: 131/52 Prognostic factors: MSKCC risk, n(%) Favourable experimental arm: 65 (35.7), control arm: 66 (36.1) Intermediate experimental arm: 104 (57.1), control arm: 104 (56.8) Poor experimental arm: 13 (7.1), control arm: 13 (7.1) Prior nephrectomy n(%) Yes all participants
Interventions	Experimental arm (n = 182): everolimus (10 mg, daily) + bevacizumab (10 mg/kg, every two weeks) Control arm (n= 183): IFN, dose escalated from 3 MIU during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks
Outcomes	Primary outcome(s) PFS Time frame: Time from randomisation to the date of radiological progressive disease as per independent central review, death from any cause, or last tumour assessment, reported between date of first participant randomised until 31Dec2011, cut‐off date Secondary outcome(s) OS Time frame: time from randomisation to the date of death from any cause, reported between date of first participant randomised and up to 2 years after the last participant randomised (data cutoff: 30 Aug2012) Number of participants who experienced AEs, SAEs and deaths Time frame: from the first participant randomised until the last patient discontinued the study treatment + 28 days Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)‐Core Quality of Life Questionnaire (QLQ‐C30) by at least 10% Relevant to this review but not reported: PFS, TFST Other outcomes (not relevant to this review): DoE, disease related symptoms, RDD, best OR
Notes	Funding sources: Novartis Pharmaceuticals. No grant numbers applied. Declarations of Interests: Quote: "All remaining authors have declared no conflicts of interest." Clinical study report available: no Study protocol available: no Statistical analysis plan available: no