{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"34"}],"units":"Participants"}],"description":"Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.","groups":[{"description":"Includes the Phase 1 dose-finding groups A, B, and C","id":"OG000","title":"Phase 1"},{"description":"Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.","id":"OG001","title":"Phase 2 - Group B"},{"description":"Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.","id":"OG002","title":"Phase 2 - Group C"}],"paramType":"NUMBER","populationDescription":"All patients who completed at least 1 cycle of treatment were included in the efficacy analysis","reportingStatus":"POSTED","timeFrame":"Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I","title":"Objective Responses Assessed by International Workshop Criteria (IWC)","type":"PRIMARY","unitOfMeasure":"participants"}