TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
C: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
D: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.


Options:
A: Objective response rate (Phase II); Survival (Phase III)
B: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
C: Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.
D: Progression-free survival rate at 6 months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.


Options:
A: disease control rate (eight weeks)
B: Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas (From randomization up to 20 months)
C: Progression-free survival rate at 6 months
D: Overall survival (A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.


Options:
A: Progression-Free Survival (PFS) (Randomization to PD or death (up to 24 months))
B: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
C: Length of survival
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.


Options:
A: Length of survival
B: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging (Up to approximately 21 months); Overall Survival (OS) (Up to approximately 21 months)
C: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
D: Progression-free survival (Event driven)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab (Bv) may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer in adjuvant setting.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens with or without bevacizumab to compare how well they work in treating patients who have undergone surgery for high risk stage II or stage III colon cancer.


Options:
A: Overall Survival (Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death))
B: Time To Progression (1 year)
C: Disease-free Survival in Stage III Cancer Patients - Time to Event (From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).); Disease-free Survival in Stage III Cancer Patients - Number of Events (From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
Brief Summary: The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.


Options:
A: Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria). (Two years); Average of Renal Function (Two years)
B: Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months (6 months)
C: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)
D: Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer
Brief Summary: The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.


Options:
A: Percentage of Participants with Complete Resection After IDS (After IDS (approximately 4 months from randomization)); Percentage of Participants with Different CC Scores After IDS (After IDS (approximately 4 months from randomization))
B: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
C: Progression Free Survival (For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years)
D: Median Progression-free Survival (PFS) in each study arm (average of 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer
Brief Summary: The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.


Options:
A: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
B: Investigator-assessed Progression-free Survival (PFS) (From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo))
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer
Brief Summary: The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.


Options:
A: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
B: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
C: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)
D: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-part Intervention to Improve Regular Care for Asthma After a Pediatric Emergency Department Visit: A Randomized Clinical Trial
Brief Summary: The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.


Options:
A: Reduce the cost of asthma health care. (18 Months)
B: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)
C: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-part Intervention to Improve Regular Care for Asthma After a Pediatric Emergency Department Visit: A Randomized Clinical Trial
Brief Summary: The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.


Options:
A: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)
B: medication adherence (on year)
C: ER visits (18 months)
D: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Hypertonic Resuscitation for Blunt Trauma
Brief Summary: The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.


Options:
A: Adult respiratory distress syndrome symptoms (measured 28 days post-injury)
B: Reduced amount of fluids given (3 days)
C: Mortality or dialysis-dependency (90 days)
D: 28-day mortality (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Brief Summary: The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).


Options:
A: Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006); Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006); Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006)
B: Progression-free Survival Time (From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.)
C: Progression-free Survival (PFS) (From randomization up to 65 months.)
D: progression-free survival (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Brief Summary: The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).


Options:
A: Overall Survival (Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death))
B: Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
C: Progression-free Survival Time (From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.)
D: Overall Survival (From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
Brief Summary: The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.


Options:
A: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation
B: Progression-free survival (PFS) (2 years after last patient in study)
C: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
D: Overall survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
Brief Summary: The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.


Options:
A: To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. (The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).)
B: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))
C: Progression-free Survival (PFS) (From randomization up to 65 months.)
D: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation

Answer: D