Statement: the primary trial and the secondary trial are not studying PFS, PBR or DLTs.
Primary_evidence: Outcome Measurement:    Concordance of Blue Dye and Lymphoseek   The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.   Time frame: Surgery after injections of Lymphoseek and blue dye Results 1:    Arm/Group Title: Intent-To-Treat   Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.   Overall Number of Participants Analyzed: 133   Overall Number of Units Analyzed   Type of Units Analyzed: Lymph Nodes  Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000        (0.9840 to 1.0000)
Secondary_evidence: Outcome Measurement:    Patient Benefit Rate at 12 Weeks   Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1   Time frame: 12 weeks from randomisation Results 1:    Arm/Group Title: Afatinib Mono   Arm/Group Description: Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.   Overall Number of Participants Analyzed: 40   Measure Type: Number   Unit of Measure: percentage of participants  30.0        (16.6 to 46.5) Results 2:    Arm/Group Title: Afatinib+Vino   Arm/Group Description: Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m  administered intravenously on days 1, 8, 15 in a 3-weekly course.   Overall Number of Participants Analyzed: 38   Measure Type: Number   Unit of Measure: percentage of participants  34.2        (19.6 to 51.4)