{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.3","value":"89.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"170"}],"units":"Participants"}],"description":"As pre-specified in the statistical analysis plan (SAP), participants in the imetelstat sodium arm group of Phase 2 and Phase 3 were pooled for pharmacokinetic (PK) data collection and analyses in this outcome measure. PK parameters were determined by population PK model.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"PK Parameter Analysis Set included all densely, and sparsely sampled participants who had received at least 1 dose of imetelstat sodium and who had sufficient data to calculate PK parameters for plasma imetelstat sodium. Overall number of participants analyzed 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: Maximum Observed Plasma Concentration (Cmax)","type":"SECONDARY","unitOfMeasure":"micrograms per milliliter (mcg/mL)"}