{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"59"}]}],"title":"Participants with AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"35"},{"groupId":"OG003","value":"15"}]}],"title":"Participants who died"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"118"},{"groupId":"OG003","value":"59"}],"units":"Participants"}],"description":"TEAEs were defined as those events that 1) occurred after the first dose of study drug, through the treatment phase, and for 30 days following the last dose of study drug or until subsequent anti-cancer therapy if earlier; 2) any event that was considered study drug-related regardless of the start date of the event; or 3) any event that was presented at baseline but worsened in severity or was subsequently considered drug-related by the investigator. Serious TEAEs are any TEAEs that result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important. Any clinically significant vital sign measurements, clinical laboratory values, and electrocardiogram (ECG) findings were reported as TEAEs. TEAEs included both serious and non-serious TEAEs.","groups":[{"description":"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: Imetelstat Sodium (No Dose Escalation)"},{"description":"Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.","id":"OG001","title":"Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)"},{"description":"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":"OG002","title":"Phase 3: Imetelstat Sodium"},{"description":"Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.","id":"OG003","title":"Phase 3: Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Phase 2 and Phase 3: Safety Analysis Set included all participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Adverse events: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3; Deaths: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3","title":"Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths","type":"SECONDARY","unitOfMeasure":"Participants"}