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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02125461
Registration number
NCT02125461
Ethics application status
Date submitted
25/04/2014
Date registered
29/04/2014
Date last updated
10/10/2023
Titles & IDs
Public title
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
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Scientific title
A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
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Secondary ID [1]
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2014-000336-42
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Secondary ID [2]
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D4191C00001
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Universal Trial Number (UTN)
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Trial acronym
PACIFIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MEDI4736
Other interventions - PLACEBO
Experimental: MEDI4736 - MEDI4736 (intravenous infusion)
Placebo Comparator: PLACEBO - Placebo (matching placebo for intravenous infusion)
Treatment: Drugs: MEDI4736
MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
Other interventions: PLACEBO
PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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Assessment method [1]
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PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.
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Timepoint [1]
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Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
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Primary outcome [2]
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Overall Survival
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Assessment method [2]
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OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
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Timepoint [2]
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From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [1]
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Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1
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Assessment method [1]
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ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
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Timepoint [1]
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Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [2]
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Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1
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Assessment method [2]
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DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.
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Timepoint [2]
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Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [3]
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Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1
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Assessment method [3]
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APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.
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Timepoint [3]
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Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
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Secondary outcome [4]
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Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1
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Assessment method [4]
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APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.
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Timepoint [4]
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Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
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Secondary outcome [5]
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Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1
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Assessment method [5]
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TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.
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Timepoint [5]
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Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [6]
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Percentage of Patients Alive at 24 Months (OS24)
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Assessment method [6]
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OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [6]
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From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [7]
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Time to Second Progression or Death (PFS2)
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Assessment method [7]
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PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [7]
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Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [8]
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Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [8]
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Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of =10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique.
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Timepoint [8]
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At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [9]
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Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)
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Assessment method [9]
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The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of =10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.
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Timepoint [9]
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At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
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Secondary outcome [10]
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Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
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Assessment method [10]
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To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.
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Timepoint [10]
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Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.
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Secondary outcome [11]
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Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
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Assessment method [11]
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ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by =4-fold following drug administration. Persistently positive was defined as positive at =2 post-baseline assessments (with =16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.
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Timepoint [11]
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Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.
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Eligibility
Key inclusion criteria
1. Age at least 18 years.
2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
3. Patients must have received at least 2 cycles of platinum-based chemotherapy
concurrent with radiation therapy.
4. World Health Organisation (WHO) Performance Status of 0 to 1.
5. Estimated life expectancy of more than 12 weeks.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
2. Active or prior autoimmune disease or history of immunodeficiency.
3. Evidence of severe or uncontrolled systemic diseases, including active bleeding
diatheses or active infections including hepatitis B, C and HIV.
4. Evidence of uncontrolled illness such as symptomatic congestive heart failure,
uncontrolled hypertension or unstable angina pectoris.
5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
colitis).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/08/2023
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Sample size
Target
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Accrual to date
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Final
713
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Bedford Park
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Research Site - Bendigo
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Research Site - Box Hill
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Research Site - Clayton
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Research Site - Heidelberg
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Research Site - Herston
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Research Site - Kogarah
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Research Site - Nedlands
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Research Site - Randwick
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Research Site - Westmead
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3550 - Bendigo
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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4029 - Herston
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Recruitment postcode(s) [7]
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2217 - Kogarah
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Recruitment postcode(s) [8]
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7250 - Launceston
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6009 - Nedlands
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2444 - Port Macquarie
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Recruitment postcode(s) [11]
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2031 - Randwick
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Recruitment postcode(s) [12]
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2145 - Westmead
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Recruitment postcode(s) [13]
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4102 - Woolloongabba
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Recruitment outside Australia
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Italy
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Milano
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Country [74]
0
0
Italy
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State/province [74]
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0
Napoli
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Country [75]
0
0
Italy
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State/province [75]
0
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Pisa
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Country [76]
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Italy
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State/province [76]
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Roma
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Country [77]
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0
Japan
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State/province [77]
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0
Bunkyo-ku
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Country [78]
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Japan
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State/province [78]
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Chuo-ku
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Country [79]
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0
Japan
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State/province [79]
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Fukuoka
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Country [80]
0
0
Japan
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State/province [80]
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0
Habikino-shi
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Country [81]
0
0
Japan
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State/province [81]
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0
Hidaka-shi
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Country [82]
0
0
Japan
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State/province [82]
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0
Hirakata-shi
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Country [83]
0
0
Japan
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State/province [83]
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0
Hiroshima-shi
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Country [84]
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Japan
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State/province [84]
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Kanazawa
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Country [85]
0
0
Japan
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State/province [85]
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0
Kashiwa
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Country [86]
0
0
Japan
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State/province [86]
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0
Kitaadachi-gun
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Country [87]
0
0
Japan
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State/province [87]
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0
Kurume-shi
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Country [88]
0
0
Japan
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State/province [88]
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0
Matsuyama-shi
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Country [89]
0
0
Japan
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State/province [89]
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0
Nagoya-shi
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Country [90]
0
0
Japan
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State/province [90]
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0
Natori-shi
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Country [91]
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Japan
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State/province [91]
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0
Okayama-shi
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Country [92]
0
0
Japan
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State/province [92]
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0
Osaka-shi
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Country [93]
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0
Japan
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State/province [93]
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0
Osakasayama
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Country [94]
0
0
Japan
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State/province [94]
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0
Ota-shi
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Country [95]
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0
Japan
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State/province [95]
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0
Sagamihara-shi
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Country [96]
0
0
Japan
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State/province [96]
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0
Sakai-shi
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Country [97]
0
0
Japan
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State/province [97]
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0
Sapporo-shi
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Country [98]
0
0
Japan
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State/province [98]
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0
Sendai-shi
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Country [99]
0
0
Japan
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State/province [99]
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0
Shinjuku-ku
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Country [100]
0
0
Japan
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State/province [100]
0
0
Sunto-gun
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Country [101]
0
0
Japan
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State/province [101]
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0
Takatsuki-shi
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Country [102]
0
0
Japan
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State/province [102]
0
0
Ube-shi
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Country [103]
0
0
Japan
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State/province [103]
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0
Yokohama-shi
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Country [104]
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0
Korea, Republic of
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State/province [104]
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Busan
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Country [105]
0
0
Korea, Republic of
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State/province [105]
0
0
Cheongju-si
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Country [106]
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Korea, Republic of
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State/province [106]
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Hwasun-gun
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Country [107]
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Korea, Republic of
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State/province [107]
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Incheon
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Country [108]
0
0
Korea, Republic of
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State/province [108]
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Seongnam-si
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Country [109]
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Korea, Republic of
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State/province [109]
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0
Seoul
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Country [110]
0
0
Korea, Republic of
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State/province [110]
0
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Suwon
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Country [111]
0
0
Mexico
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State/province [111]
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Cuautitlan Izcalli
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Country [112]
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Mexico
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State/province [112]
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Monterrey
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Country [113]
0
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Mexico
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State/province [113]
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Oaxaca
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Country [114]
0
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Mexico
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State/province [114]
0
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Orizaba
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Country [115]
0
0
Netherlands
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State/province [115]
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Amsterdam
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Country [116]
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Netherlands
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State/province [116]
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Breda
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Country [117]
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Netherlands
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State/province [117]
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Eindhoven
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Country [118]
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Netherlands
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State/province [118]
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0
Rotterdam
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Country [119]
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0
Netherlands
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State/province [119]
0
0
Tilburg
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Country [120]
0
0
Peru
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State/province [120]
0
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Lima
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Country [121]
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0
Poland
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State/province [121]
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Gdansk
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Country [122]
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Poland
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State/province [122]
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Lublin
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Country [123]
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Poland
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State/province [123]
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Warszawa
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Country [124]
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Singapore
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State/province [124]
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Singapore
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Country [125]
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0
Slovakia
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State/province [125]
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Bardejov
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Country [126]
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0
Slovakia
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State/province [126]
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0
Kosice
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Country [127]
0
0
Slovakia
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State/province [127]
0
0
Nove Zamky
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Country [128]
0
0
Slovakia
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State/province [128]
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Trnava
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Country [129]
0
0
South Africa
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State/province [129]
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Cape Town
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Country [130]
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0
South Africa
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State/province [130]
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Pretoria
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Country [131]
0
0
South Africa
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State/province [131]
0
0
Vereeniging
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Country [132]
0
0
Spain
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State/province [132]
0
0
Alicante
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Country [133]
0
0
Spain
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State/province [133]
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Barcelona
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Country [134]
0
0
Spain
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State/province [134]
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Gerona
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Country [135]
0
0
Spain
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State/province [135]
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0
Lérida
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Country [136]
0
0
Spain
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State/province [136]
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Madrid
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Country [137]
0
0
Spain
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State/province [137]
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0
San Sebastian
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Country [138]
0
0
Spain
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State/province [138]
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0
Sevilla
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Country [139]
0
0
Spain
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State/province [139]
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0
Valencia
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Country [140]
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0
Spain
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State/province [140]
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0
Zaragoza
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Country [141]
0
0
Taiwan
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State/province [141]
0
0
Taichung
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Country [142]
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0
Taiwan
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State/province [142]
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0
Taipei City
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Country [143]
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0
Taiwan
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State/province [143]
0
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Taipei
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Country [144]
0
0
Thailand
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State/province [144]
0
0
Bangkok
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Country [145]
0
0
Thailand
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State/province [145]
0
0
Hat Yai
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Country [146]
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0
Thailand
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State/province [146]
0
0
Muang
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Country [147]
0
0
Turkey
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State/province [147]
0
0
Adana
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Country [148]
0
0
Turkey
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State/province [148]
0
0
Ankara
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Country [149]
0
0
Turkey
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State/province [149]
0
0
Istanbul
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Country [150]
0
0
Turkey
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State/province [150]
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0
Izmir
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Country [151]
0
0
Turkey
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State/province [151]
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0
Konya
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Country [152]
0
0
Turkey
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State/province [152]
0
0
Malatya
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Country [153]
0
0
United Kingdom
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State/province [153]
0
0
Glasgow
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Country [154]
0
0
United Kingdom
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State/province [154]
0
0
Manchester
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Country [155]
0
0
United Kingdom
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State/province [155]
0
0
Truro
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Country [156]
0
0
Vietnam
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State/province [156]
0
0
Hanoi
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Country [157]
0
0
Vietnam
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State/province [157]
0
0
Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in
Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02125461
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Phil Dennis, MD
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Address
0
0
AstraZeneca
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02125461
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