Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02477696
Registration number
NCT02477696
Ethics application status
Date submitted
12/06/2015
Date registered
23/06/2015
Titles & IDs
Public title
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
Query!
Scientific title
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
Query!
Secondary ID [1]
0
0
2014-005530-64
Query!
Secondary ID [2]
0
0
ACE-CL-006
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Ibrutinib
Experimental: Acalabrutinib - Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first.
Active comparator: Ibrutinib - Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first.
Treatment: Drugs: Acalabrutinib
Participants will receive oral acalabrutinib as stated in arm description.
Treatment: Drugs: Ibrutinib
Participants will receive oral ibrutinib as stated in arm description.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment
Query!
Assessment method [1]
0
0
The PFS is defined as the time from date of randomization to the date of first IRC-assessed PD or death due to any cause, whichever occurred first. PD (per International Workshop on Chronic Lymphocytic Leukemia \[iwCLL\] 2008 criteria): Lymphocytes \>= 50% increase over baseline, or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, or \>= 50% platelets or \> 2 g/dL hemoglobin decreases from baseline secondary to chronic lymphocytic leukemia (CLL). The PFS is assessed using the Kaplan-Meier method.
Query!
Timepoint [1]
0
0
Baseline (Days -28 to -1) through 55.2 months (maximum observed duration)
Query!
Secondary outcome [1]
0
0
Number of Participants With Treatment-emergent Infections Grade >= 3
Query!
Assessment method [1]
0
0
Number of participants with treatment-emergent infections Grade \>=3 are reported.
Query!
Timepoint [1]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [2]
0
0
Number of Participants With Treatment-emergent Richter's Transformation
Query!
Assessment method [2]
0
0
Richter's transformation is defined as the occurrence of an aggressive lymphoma in participants with a previous or concomitant diagnosis of CLL. Richter's transformation was assessed by central pathology. Number of participants with treatment-emergent Richter's transformation are reported.
Query!
Timepoint [2]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [3]
0
0
Number of Participants With Treatment-emergent Atrial Fibrillation
Query!
Assessment method [3]
0
0
Number of participants with treatment-emergent atrial fibrillation (including atrial flutter) are reported.
Query!
Timepoint [3]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [4]
0
0
Overall Survival (OS)
Query!
Assessment method [4]
0
0
The OS is defined as the time from date of randomization to date of death due to any cause. The OS is assessed using the Kaplan-Meier method.
Query!
Timepoint [4]
0
0
Baseline (Days -28 to -1) through 83.7 months (maximum observed duration)
Query!
Secondary outcome [5]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Query!
Assessment method [5]
0
0
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Query!
Timepoint [5]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [6]
0
0
Number of Participants With Treatment-emergent Laboratory Abnormalities
Query!
Assessment method [6]
0
0
Number of participants with treatment-emergent laboratory abnormalities are reported. Laboratory abnormality is defined as any abnormal finding during analysis of hematology and serum chemistry.
Query!
Timepoint [6]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [7]
0
0
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Query!
Assessment method [7]
0
0
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, heart rate, and respiratory rate).
Query!
Timepoint [7]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Lymphocytosis
Query!
Assessment method [8]
0
0
Percentage of participants with at least one occurrence of treatment-related lymphocytosis defined as an elevation in ALC of \>= 50% compared with baseline and a postbaseline assessment of \> 5000/µL in the peripheral blood are reported.
Query!
Timepoint [8]
0
0
Day 1 through 83.5 months (maximum observed duration)
Query!
Secondary outcome [9]
0
0
Number of Participants With Electrocardiogram (ECG) Abnormality at Baseline
Query!
Assessment method [9]
0
0
Number of participants with ECG abnormality at baseline are reported.
Query!
Timepoint [9]
0
0
Baseline (Days -28 to -1)
Query!
Secondary outcome [10]
0
0
Number of Participants With Shift From Baseline to Worst (Grade 3 and 4) Postbaseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Query!
Assessment method [10]
0
0
The ECOG performance status assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=death. Number of participants with shift from baseline (Days -28 to -1) to worst Grade 3 and 4 in ECOG performance status are reported.
Query!
Timepoint [10]
0
0
Baseline (Days -28 to -1) through 83.5 months (maximum observed duration)
Query!
Eligibility
Key inclusion criteria
* Men and women = 18 years of age.
* ECOG performance status of 0 to 2.
* Diagnosis of CLL.
* Must have = 1 of the following high-risk prognostic factors:
* Presence of 17p del by central laboratory.
* Presence of 11q del by central laboratory.
* Active disease meeting = 1 of the following IWCLL 2008 criteria for requiring treatment
* Must have received = 1 prior therapies for CLL.
* Meet the following laboratory parameters:
* Absolute neutrophil count (ANC) = 750 cells/µL or = 500 cells/µL in participants with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
* Platelet count = 30,000 cells/µL without transfusion support 7 days before assessment. Participants with transfusion-dependent thrombocytopenia are excluded.
* Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) = 3.0 x upper limit of normal (ULN).
* Total bilirubin = 1.5 x ULN.
* Estimated creatinine clearance = 30 mL/min.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Known CNS lymphoma or leukemia.
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
* Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
* Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor or a B-cell lymphoma-2 (BCL-2) inhibitor.
* Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
* Prior radio- or toxin-conjugated antibody therapy.
* Prior allogeneic stem cell or autologous transplant.
* Major surgery within 4 weeks before first dose of study drug.
* Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence.
* Significant cardiovascular disease within 6 months of screening.
* Known history of infection with human immunodeficiency virus (HIV).
* History of stroke or intracranial hemorrhage within 6 months before randomization.
* History of bleeding diathesis.
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
* Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
3/01/2028
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
533
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Research Site - Frankston
Query!
Recruitment hospital [3]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [4]
0
0
Research Site - St Leonards
Query!
Recruitment hospital [5]
0
0
Research Site - Waratah NSW
Query!
Recruitment hospital [6]
0
0
Research Site - Wollongong
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [3]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
2298 - Waratah NSW
Query!
Recruitment postcode(s) [6]
0
0
2500 - Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kansas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Montana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Pennsylvania
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Virginia
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Washington
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Wisconsin
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Brugge
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Bruxelles
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Ghent
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Leuven
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Yvoir
Query!
Country [23]
0
0
Denmark
Query!
State/province [23]
0
0
Aalborg
Query!
Country [24]
0
0
Denmark
Query!
State/province [24]
0
0
Indgang 27B
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Bobigny
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Creteil
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Pierre-Benite
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Rennes Cedex
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Rouen
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Toulouse Cedex
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
München
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Ulm
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Budapest
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Debrecen
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Kaposvár
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
Haifa
Query!
Country [37]
0
0
Israel
Query!
State/province [37]
0
0
Jerusalem
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Nahariya
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Petah Tikvah
Query!
Country [40]
0
0
Israel
Query!
State/province [40]
0
0
Tel Hashomer
Query!
Country [41]
0
0
Israel
Query!
State/province [41]
0
0
Tiberias
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Bologna
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Cagliari
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Cona
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Firenze
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Meldola
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Milano
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Milan
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Modena
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Ravenna
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Rome
Query!
Country [52]
0
0
Netherlands
Query!
State/province [52]
0
0
Almere
Query!
Country [53]
0
0
Netherlands
Query!
State/province [53]
0
0
Amsterdam
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Blaricum
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Breda
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Delft
Query!
Country [57]
0
0
Netherlands
Query!
State/province [57]
0
0
Dordrecht
Query!
Country [58]
0
0
Netherlands
Query!
State/province [58]
0
0
Geleen
Query!
Country [59]
0
0
Netherlands
Query!
State/province [59]
0
0
Groningen
Query!
Country [60]
0
0
Netherlands
Query!
State/province [60]
0
0
Haarlem
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Leiden
Query!
Country [62]
0
0
Netherlands
Query!
State/province [62]
0
0
Rotterdam
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Utrecht
Query!
Country [64]
0
0
Netherlands
Query!
State/province [64]
0
0
Zutphens
Query!
Country [65]
0
0
New Zealand
Query!
State/province [65]
0
0
Addington
Query!
Country [66]
0
0
New Zealand
Query!
State/province [66]
0
0
Auckland
Query!
Country [67]
0
0
New Zealand
Query!
State/province [67]
0
0
Tauranga
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bydgoszcz
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Gdansk
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdynia
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Kraków
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Lodz
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Olsztyn
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Opole
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Slupsk
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Wroclaw
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Barcelona
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Madrid
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Majadahonda
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Murcia
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Santander
Query!
Country [82]
0
0
Turkey
Query!
State/province [82]
0
0
Ankara
Query!
Country [83]
0
0
Turkey
Query!
State/province [83]
0
0
Instabul
Query!
Country [84]
0
0
Turkey
Query!
State/province [84]
0
0
Istanbul
Query!
Country [85]
0
0
Turkey
Query!
State/province [85]
0
0
Izmir
Query!
Country [86]
0
0
Turkey
Query!
State/province [86]
0
0
Kayseri
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Birmingham
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Bournemouth
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Cambridge
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Cardiff
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Greater London
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Hull
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Leeds
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Leicester
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Liverpool
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
London
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Manchester
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Nottingham
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Plymouth
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Southampton
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Surrey
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Acerta Pharma BV
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02477696
Query!
Trial related presentations / publications
Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536. Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Yenerel MN, Illes A, Kay N, Garcia-Marco JA, Mato A, Pinilla-Ibarz J, Seymour JF, Lepretre S, Stilgenbauer S, Robak T, Rothbaum W, Izumi R, Hamdy A, Patel P, Higgins K, Sohoni S, Jurczak W. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021 Nov 1;39(31):3441-3452. doi: 10.1200/JCO.21.01210. Epub 2021 Jul 26.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Acerta Clinical Trials
Query!
Address
0
0
1-888-292-9613
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/96/NCT02477696/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT02477696/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02477696