{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"description":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Single agent intravenous (IV) mithramycin\n\nMithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.","id":"OG000","title":"Dose Level 1 - 30 mcg/kg Thoracic Malignancy"},{"description":"Single agent intravenous (IV) mithramycin\n\nMithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.","id":"OG001","title":"Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy"},{"description":"Single agent intravenous (IV) mithramycin\n\nMithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).","id":"OG002","title":"Dose Level -1 - 25 mcg/kg Thoracic Malignancy"},{"description":"Single agent intravenous (IV) mithramycin\n\nMithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).","id":"OG003","title":"Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approx. 9 mos & 6 days DL1 30 mcg/kg thoracic group, 2 mos & 16 days DL1 30 mcg/kg extra-thoracic group, 5 mos & 26 days DL-1 25 mcg/kg thoracic group, & 20 days DL-1 25 mcg/kg extra-thoracic group","title":"Number of Participants With Serious and Non-Serious Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}