{"analyses":[{"ciLowerLimit":"-0.138","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.260","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Mean Difference (Final Values)","paramValue":"0.061","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.12","value":"0.05"},{"groupId":"OG001","spread":"0.56","value":"0.25"}]}],"title":"Summary of difference from baseline in P"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.25","value":"0.14"},{"groupId":"OG001","spread":"0.36","value":"0.22"}]}],"title":"Summary of difference from baseline in C"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.26","value":"0.12"},{"groupId":"OG001","spread":"0.59","value":"0.35"}]}],"title":"Summary of difference from baseline in NO"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"description":"To study the change in cataract from baseline visit to months 12, regarding the three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. 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).\n\nThe LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each.","dispersionType":"Standard Deviation","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":"MEAN","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 12","title":"Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 12.","type":"SECONDARY","unitOfMeasure":"units on a scale"}