{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"166"}],"units":"Participants"}],"description":"As pre-specified in the SAP, participants in the imetelstat sodium arm group of Phase 2 and Phase 3 were pooled for immunogenicity data collection and analyses in this outcome measure. Percentages were rounded off to the nearest single decimal place.","groups":[{"description":"For Phase 2: Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.\n\nFor Phase 3: Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.","id":"OG000","title":"Phase 2 and Phase 3: Imetelstat Sodium"}],"paramType":"NUMBER","populationDescription":"The Pharmacodynamic (PD) Analysis Set included all participants who had at least one quantifiable post-dose determination on biomarker, efficacy or safety parameters as defined in the related Pharmacodynamics analysis plan. Overall number of participants analysed signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Pre-dose on Cycle 1 Day 1 and pre-dose on Day 1 of every 3 cycles from Cycle 4 up to Cycle 66 in Phase 2 and Cycle 34 in Phase 3 (each cycle length= 28 days)","title":"Phase 2 and Phase 3: Percentage of Participants With Anti-drug Antibodies (ADA) to Imetelstat Sodium","type":"SECONDARY","unitOfMeasure":"percentage of participants"}