{"denoms":[{"counts":[{"groupId":"BG000","value":"200"},{"groupId":"BG001","value":"200"},{"groupId":"BG002","value":"400"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"B: Placebo+BIC"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"179"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"108"},{"groupId":"BG001","value":"113"},{"groupId":"BG002","value":"221"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"25","upperLimit":"89","value":"65"},{"groupId":"BG001","lowerLimit":"31","upperLimit":"81","value":"67"},{"groupId":"BG002","lowerLimit":"25","upperLimit":"89","value":"66"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"99"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"156"},{"groupId":"BG001","value":"145"},{"groupId":"BG002","value":"301"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"198"},{"groupId":"BG001","value":"197"},{"groupId":"BG002","value":"395"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"8"}]}],"title":"Canada"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"7"}]}],"title":"Netherlands"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}],"title":"Sweden"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"13"}]}],"title":"Belgium"},{"categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"26"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}],"title":"Ireland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"36"}]}],"title":"Egypt"},{"categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"31"}]}],"title":"Poland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"163"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"95"}]}],"title":"United Kingdom"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}]}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}],"title":"Spain"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}],"populationDescription":"Patients ≥ 18 years with advanced malignant pleural mesothelioma previously treated with a pemetrexed based chemotherapy regimen for advanced or metastatic disease."}