{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.18","groupDescription":"Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.58","pValueComment":"The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.","paramType":"Hazard Ratio (HR)","paramValue":"0.94","statisticalComment":"Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.2","upperLimit":"9.9","value":"8.5"},{"groupId":"OG001","lowerLimit":"6.6","upperLimit":"8.9","value":"8.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"200"}],"units":"Participants"}],"description":"Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive","dispersionType":"95% Confidence Interval","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":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}