{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"41"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"41"}],"units":"Participants"}],"description":"Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for 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":"Phase I Dose Level (DL) 1 Topotecan 1mg/m\\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\\^2 IV on day 5","id":"OG000","title":"Phase I DL 1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5"},{"description":"Phase I Dose Level (DL) 2 Topotecan 1mg/m\\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\\^2 IV on day 2, 5","id":"OG001","title":"Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5"},{"description":"Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\\^2 IV on day 2, 5","id":"OG002","title":"Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5"},{"description":"Phase I Dose Level (DL) 4 Topotecan 1.25mg/m\\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\\^2 IV on day 2, 5","id":"OG003","title":"Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5"},{"description":"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\\^2 IV on day 2, 5.\n\nMaximum Tolerated Dose/Recommended Phase II Dose.\n\n26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group.","id":"OG004","title":"Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 9 months and 9 days for Ph I DL1, 42 months and 12 days for Ph I DL2, 15 months and 9 days for Ph I DL3, 17 months and 9 days for Ph I DL4, and 43 months and 22 days for Ph II DL4.","title":"Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)","type":"PRIMARY","unitOfMeasure":"Participants"}