{"analyses":[{"ciLowerLimit":"-21.669","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"33.43","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValueComment":"According to statistical analysis plan it was not planned to calculate any P-Value.","paramType":"Risk Difference (RD)","paramValue":"5.88","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"23"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"30"}]}],"title":"No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"26"}]}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"description":"Number of participants from the primary cataract subset showing an increase from baseline of \\>= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are 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. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).","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":"Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.","reportingStatus":"POSTED","timeFrame":"6 Months","title":"Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.","type":"SECONDARY","unitOfMeasure":"participants"}