{"analyses":[{"ciLowerLimit":"0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.26","groupDescription":"QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.","nonInferiorityType":"OTHER","pValue":"0.5806","paramType":"Hazard Ratio (HR)","paramValue":"0.92","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"4.4","value":"3.2"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"3.4","value":"3.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"175"},{"groupId":"OG001","value":"185"}],"units":"Participants"}],"description":"Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.","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","populationDescription":"Participants with a worsening in the average symptom burden index by 25%.","reportingStatus":"POSTED","timeFrame":"from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)","title":"Time to LCSS Symptomatic Progression","type":"SECONDARY","unitOfMeasure":"months"}