{"classes":[{"categories":[{"measurements":[{"comment":"Median and Lower end of confidence interval is not estimable for 1 participant.","groupId":"OG000","lowerLimit":"66.5","upperLimit":"NA","value":"NA"},{"comment":"No partial response.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"No partial response.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and Lower end of confidence interval is not estimable for 1 participant.","groupId":"OG003","lowerLimit":"53.4","upperLimit":"NA","value":"NA"},{"groupId":"OG004","lowerLimit":"0.6","upperLimit":"6.9","value":"4.9"},{"groupId":"OG005","lowerLimit":"4.4","upperLimit":"6.9","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"25"},{"groupId":"OG005","value":"15"}],"units":"Participants"}],"description":"DOR is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented in response to the combination in both platinum sensitive and refractory patients. CR is disappearance of all non-target lesions and normalization of tumor marker level. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.","dispersionType":"95% Confidence Interval","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 DL1 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 DL 2 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.","id":"OG004","title":"Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV"},{"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.","id":"OG005","title":"Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV"}],"paramType":"MEDIAN","populationDescription":"1/26 participants were not evaluable in the Phase II DL4 SCLC group. The Phase II, DL4 Arm/Group is split into two groups for this outcome measure because the distinction is relevant for the phase II, DL4 since extrapulmonary small cell cancers (EPSCC) was an exploratory cohort of the phase II DL4 (added with an amendment). Only 1 participant was evaluable in Phase 1 DL1 and Phase 1 DL4.","reportingStatus":"POSTED","timeFrame":"At disease progression, an average of 5.25 months.","title":"Phase I and Phase II: Duration of Response (DOR)","type":"SECONDARY","unitOfMeasure":"Months"}