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/NCT03847428
Registration number
NCT03847428
Ethics application status
Date submitted
18/02/2019
Date registered
20/02/2019
Titles & IDs
Public title
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
Query!
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Query!
Secondary ID [1]
0
0
2018-004105-85
Query!
Secondary ID [2]
0
0
D910DC00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EMERALD-2
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Liver
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Bevacizumab
Other interventions - Placebo
Experimental: Arm A - Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
Experimental: Arm B - Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
Placebo comparator: Arm C - Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
Treatment: Drugs: Durvalumab
Durvalumab IV (intravenous)
Treatment: Drugs: Bevacizumab
Bevacizumab IV (intravenous)
Other interventions: Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Recurrence-free survival (RFS) for Arm A vs Arm C
Query!
Assessment method [1]
0
0
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Query!
Timepoint [1]
0
0
Up to 49 months after first patient randomized
Query!
Secondary outcome [1]
0
0
Recurrence-free survival (RFS) Arm B vs Arm C
Query!
Assessment method [1]
0
0
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Query!
Timepoint [1]
0
0
Up to 49 months after first patient randomized
Query!
Secondary outcome [2]
0
0
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
Query!
Assessment method [2]
0
0
OS is defined as the time from the date of randomization until death due to any cause
Query!
Timepoint [2]
0
0
No timeframe
Query!
Secondary outcome [3]
0
0
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
Query!
Assessment method [3]
0
0
Proportion of RFS at 24 months and at 36 months
Query!
Timepoint [3]
0
0
At 24 and at 36 months
Query!
Secondary outcome [4]
0
0
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
Query!
Assessment method [4]
0
0
TTR is defined as the time from the date of randomization until the date of disease recurrence
Query!
Timepoint [4]
0
0
Up to 49 months after first patient randomized
Query!
Secondary outcome [5]
0
0
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
Query!
Assessment method [5]
0
0
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Query!
Timepoint [5]
0
0
Up to 49 months after first patient randomized
Query!
Eligibility
Key inclusion criteria
* Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
* Imaging to confirm disease-free status within 28 days prior to randomization
* ECOG 0-1 at enrolment
* Child-Pugh score of 5 or 6
* Adequate organ and marrow function.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
150
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
* History of hepatic encephalopathy within 12 months prior to randomization
* Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
* Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
* Active co-infection with HBV and HDV.
* Receipt of prior systemic anticancer therapy for HCC
* Those on a waiting list for liver transplantation
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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
29/04/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/05/2027
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
908
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [2]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [3]
0
0
Research Site - Nedlands
Query!
Recruitment hospital [4]
0
0
Research Site - Westmead
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [4]
0
0
2145 - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Mexico
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
South Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Tennessee
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Wisconsin
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Innsbruck
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Linz
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
St. Pölten
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Florianópolis
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Porto Alegre
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Rio de Janeiro
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Santa Maria
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Santo Andre
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
São José do Rio Preto
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Vitória
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Quebec
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Beijing
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Bengbu
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Changchun
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Changsha
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chengdu
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Fuzhou
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Guangzhou
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Hangzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Harbin
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Hefei
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Hohhot
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Nanjing
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Ningbo
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Shanghai
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Tianjin
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Urumqi
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Wuhan
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Xi'an
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Zhengzhou
Query!
Country [55]
0
0
Egypt
Query!
State/province [55]
0
0
Alexandria
Query!
Country [56]
0
0
Egypt
Query!
State/province [56]
0
0
Assiut
Query!
Country [57]
0
0
Egypt
Query!
State/province [57]
0
0
Cairo
Query!
Country [58]
0
0
Egypt
Query!
State/province [58]
0
0
Dakahlia
Query!
Country [59]
0
0
Egypt
Query!
State/province [59]
0
0
New Cairo
Query!
Country [60]
0
0
Egypt
Query!
State/province [60]
0
0
Shebeen El Kom
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Amiens Cedex 1
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
ANGERS Cedex 9
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Besançon
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Clichy
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Dijon Cedex
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Nantes
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Nice
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
PARIS Cedex 12
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Pessac
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Toulouse Cedex 9
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
TOURS Cedex 9
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Berlin
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Bonn
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Chemnitz
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Freiburg
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Heidelberg
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Köln
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Leipzig
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Lübeck
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
München
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Tuebingen
Query!
Country [82]
0
0
Hong Kong
Query!
State/province [82]
0
0
Hong Kong
Query!
Country [83]
0
0
Hong Kong
Query!
State/province [83]
0
0
HongKong
Query!
Country [84]
0
0
Hong Kong
Query!
State/province [84]
0
0
Kwai Chung
Query!
Country [85]
0
0
Hong Kong
Query!
State/province [85]
0
0
Shatin
Query!
Country [86]
0
0
India
Query!
State/province [86]
0
0
Bangalore
Query!
Country [87]
0
0
India
Query!
State/province [87]
0
0
Hyderabad
Query!
Country [88]
0
0
India
Query!
State/province [88]
0
0
Kolkata
Query!
Country [89]
0
0
India
Query!
State/province [89]
0
0
Mumbai
Query!
Country [90]
0
0
India
Query!
State/province [90]
0
0
New Delhi
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Bologna
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Milano
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Napoli
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Roma
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Tricase, Lecce
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Verona
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Bunkyo-ku
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Fukuoka-shi
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Gifu-shi
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Hiroshima-shi
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Koto-ku
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Kumamoto-shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Kurume-shi
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Kyoto-shi
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Matsuyama-shi
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Mitaka-shi
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Musashino-shi
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Nagasaki-shi
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Nagoya-shi
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Osaka-shi
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Osakasayama-shi
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Sapporo-shi
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Sendai-shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Shinagawa-ku
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Shinjuku-ku
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Shiwa-gun
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Takasaki-shi
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Tsu-shi
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Wakayama-shi
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Yokohama-shi
Query!
Country [121]
0
0
Korea, Republic of
Query!
State/province [121]
0
0
Busan
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Daegu
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Seoul
Query!
Country [124]
0
0
Peru
Query!
State/province [124]
0
0
Lima
Query!
Country [125]
0
0
Peru
Query!
State/province [125]
0
0
San Isidro
Query!
Country [126]
0
0
Philippines
Query!
State/province [126]
0
0
Manila
Query!
Country [127]
0
0
Philippines
Query!
State/province [127]
0
0
Muntinlupa City
Query!
Country [128]
0
0
Philippines
Query!
State/province [128]
0
0
Pasig City
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Bydgoszcz
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Gdansk
Query!
Country [131]
0
0
Poland
Query!
State/province [131]
0
0
Poznan
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Warszawa
Query!
Country [133]
0
0
Puerto Rico
Query!
State/province [133]
0
0
Ponce
Query!
Country [134]
0
0
Russian Federation
Query!
State/province [134]
0
0
Barnaul
Query!
Country [135]
0
0
Russian Federation
Query!
State/province [135]
0
0
Ekaterinburg
Query!
Country [136]
0
0
Russian Federation
Query!
State/province [136]
0
0
Moscow
Query!
Country [137]
0
0
Russian Federation
Query!
State/province [137]
0
0
Obninsk
Query!
Country [138]
0
0
Russian Federation
Query!
State/province [138]
0
0
Saint Petersburg
Query!
Country [139]
0
0
Russian Federation
Query!
State/province [139]
0
0
Saint-Petersburg
Query!
Country [140]
0
0
Singapore
Query!
State/province [140]
0
0
Singapore
Query!
Country [141]
0
0
Taiwan
Query!
State/province [141]
0
0
Changhua
Query!
Country [142]
0
0
Taiwan
Query!
State/province [142]
0
0
Tainan
Query!
Country [143]
0
0
Taiwan
Query!
State/province [143]
0
0
Taipei
Query!
Country [144]
0
0
Taiwan
Query!
State/province [144]
0
0
Taoyuan City
Query!
Country [145]
0
0
Taiwan
Query!
State/province [145]
0
0
Yunlin
Query!
Country [146]
0
0
Thailand
Query!
State/province [146]
0
0
Bangkok
Query!
Country [147]
0
0
Thailand
Query!
State/province [147]
0
0
Chiang Mai
Query!
Country [148]
0
0
Thailand
Query!
State/province [148]
0
0
Hat Yai
Query!
Country [149]
0
0
Thailand
Query!
State/province [149]
0
0
Khon Kaen
Query!
Country [150]
0
0
Thailand
Query!
State/province [150]
0
0
Pathumthani
Query!
Country [151]
0
0
Turkey
Query!
State/province [151]
0
0
Ankara
Query!
Country [152]
0
0
Turkey
Query!
State/province [152]
0
0
Istanbul
Query!
Country [153]
0
0
Turkey
Query!
State/province [153]
0
0
Izmir
Query!
Country [154]
0
0
Turkey
Query!
State/province [154]
0
0
Malatya
Query!
Country [155]
0
0
Vietnam
Query!
State/province [155]
0
0
Hanoi
Query!
Country [156]
0
0
Vietnam
Query!
State/province [156]
0
0
Ho Chi Minh city
Query!
Country [157]
0
0
Vietnam
Query!
State/province [157]
0
0
Ho Chi Minh
Query!
Country [158]
0
0
Vietnam
Query!
State/province [158]
0
0
Hochiminh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03847428
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jia Fan, PhD
Query!
Address
0
0
Liver Cancer Institute Zhongshan Hospital, Fudan University
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
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 de-identified 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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03847428