{"analyses":[{"ciLowerLimit":"0.76","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.68","estimateComment":"Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner","groupDescription":"Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.62","paramType":"Odds Ratio (OR)","paramValue":"1.13","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"109"}]}],"title":"Disease control rate (DCR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}]}],"title":"Complete or partial response (CR o PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"103"}]}],"title":"Stable disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"71"}]}],"title":"Progressive disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"20"}]}],"title":"Nonassessable (NA)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"200"}],"units":"Participants"}],"description":"Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria","groups":[{"description":"NGR-hTNF plus Best Investigator's Choice\n\nNGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.\n\n* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis\n* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:\n\n  1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles\n  2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles\n  3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)","id":"OG000","title":"A: NGR-hTNF + BIC"},{"description":"Placebo plus Best Investigator's Choice\n\nPlacebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.\n\n* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis\n* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:\n\n  1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles\n  2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles\n  3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)","id":"OG001","title":"B: Placebo+BIC"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Assessed every 6-12 weeks, up to 100 weeks","title":"Disease Control Rate (DCR)","type":"SECONDARY","unitOfMeasure":"Participants"}