{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}],"units":"Participants"}],"description":"A DLT is defined using the Common Terminology Criteria in Adverse Events (CTCAE) v4.0 and is related or possibly drug related, such as neutropenia Grade 4 for \\>7 days duration, febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection), or Grade 3 thrombocytopenia. Death due to drug related adverse events.","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 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"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"End of Cycle 1, approximately 3 weeks","title":"Phase I Number of Participants With a Dose Limiting Toxicity (DLT)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}