{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"M60: Mobility - No problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"M60: Mobility - Some problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"M60: Mobility - Severe problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"M60: Self-care - No problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"M60: Self-care - Some problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"M60: Self-care - Severe problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"M60: Usual activities - No problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"M60: Usual activities - Some problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"M60: Usual activities - Severe problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"M60: Pain/discomfort - No problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"M60: Pain/discomfort - Some problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"M60: Pain/discomfort - Severe problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"M60: Anxiety/depression - No problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"M60: Anxiety/depression - Some problems"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"M60: Anxiety/depression - Severe problems"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Results from the EQ-5D questionnaire is for number of participants who achieved CR or CRi at month 60. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression. Respondents are asked to choose the statement in each dimension that best describes their health status on the day surveyed. Their responses are coded as a number (1, 2, or 3) that corresponds to the respective level of severity: 1 indicates no problems, 2 some problems, and 3 severe problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The scores are then normalized to a value from 0-100 where higher scores = better HRQOL \\& fewer problems or symptoms.","groups":[{"description":"Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).","id":"OG000","title":"Main Cohort: Single Dose of CTL019"},{"description":"Pediatric B-ALL patients who are very high risk at first relapse.","id":"OG001","title":"Cohort 1: Single Dose of CTL019"}],"paramType":"NUMBER","populationDescription":"FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel and who had evaluable results at the measured time points. This analysis included a subset of FAS who had any data of the particular questionnaire at the measured timepoints. Therefore, no participants in Cohort 1 had questionnaire data for tisagenlecleucel at the measured time points, so no data was collected for Cohort 1.","reportingStatus":"POSTED","timeFrame":"Month 60","title":"Effects of CTL019 Therapy on Patient Reported Outcomes as Measured by EQ-5D Questionnaire","type":"SECONDARY","unitOfMeasure":"Participants"}