{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"5"}]}],"title":"P month 6 - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"47"}]}],"title":"P, month 6 - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"13"}]}],"title":"P, month 12 - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"39"}]}],"title":"P, month 12 - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"}]}],"title":"C month 6 - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"43"}]}],"title":"C, month 6 - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"13"}]}],"title":"C, month 12 - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"39"}]}],"title":"C, month 12 - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"19"}]}],"title":"NO month 6 - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"33"}]}],"title":"NO month 6 - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"20"}]}],"title":"NO month 12 - Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"32"}]}],"title":"NO month 12 - No"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"27"}]}],"title":"P, C and NO, month 6 - Subjects who discontinued"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"27"}]}],"title":"P, C and NO, month 12 - Subjects who discontinued"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"description":"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 (P), Cortical Cataract (C) and Nuclear Opalescence (NO).\n\nFor Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference.","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":"281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 \\[77.3%\\] in the placebo, 52/79 \\[65.8%\\] in the palifermin. Month 12: 66 completed (14/22 \\[63.6%\\] in the placebo, 52/79 \\[65.8%\\] in the palifermin group.","reportingStatus":"POSTED","timeFrame":"at Month 6 and Month 12","title":"Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12","type":"SECONDARY","unitOfMeasure":"participants"}