{"analyses":[{"ciLowerLimit":"-0.134","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.181","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Mean Difference (Net)","paramValue":"0.023","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.08","value":"0.01"},{"groupId":"OG001","spread":"0.40","value":"0.12"}]}],"title":"Summary of difference from baseline in P"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.29","value":"0.14"},{"groupId":"OG001","spread":"0.28","value":"0.15"}]}],"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 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale.\n\nTo 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 theLOCS 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 6","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 6.","type":"SECONDARY","unitOfMeasure":"units on a scale"}