{"analyses":[{"ciLowerLimit":"-21.641","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.264","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Risk Difference (RD)","paramValue":"-3.689","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}],"title":"Incidence of decrease in letters read - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"48"}]}],"title":"Incidence of decrease in letters read - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"27"}]}],"title":"Subjects who discontinued at Month 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"description":"To study if the treatment has effected on the visual acuity from baseline to months 6, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).","groups":[{"description":"Subjects to receive matched placebo before- and after-high dose chemotherapy.","id":"OG000","title":"Placebo"},{"description":"Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.","id":"OG001","title":"Palifermin"}],"paramType":"NUMBER","populationDescription":"All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.","reportingStatus":"POSTED","timeFrame":"Months 6","title":"Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 6","type":"SECONDARY","unitOfMeasure":"participants"}