Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT01566721




Registration number
NCT01566721
Ethics application status
Date submitted
22/03/2012
Date registered
29/03/2012

Titles & IDs
Public title
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Scientific title
A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
Secondary ID [1] 0 0
2011-005328-17
Secondary ID [2] 0 0
MO28048
Universal Trial Number (UTN)
Trial acronym
SafeHER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Herceptin

Experimental: Cohort A: SC Herceptin by Needle/Syringe - Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.

Experimental: Cohort B: SC Herceptin by SID - Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.


Treatment: Drugs: Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Timepoint [1] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [2] 0 0
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
Timepoint [2] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [3] 0 0
Percentage of Participants With Treatment Interruption Due to an AE
Timepoint [3] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [4] 0 0
Number of Herceptin Cycles Received
Timepoint [4] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [5] 0 0
Percentage of Participants by Total Number of Herceptin Cycles Received
Timepoint [5] 0 0
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary outcome [6] 0 0
Percentage of Participants Who Received Concomitant Cancer Therapy
Timepoint [6] 0 0
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Primary outcome [7] 0 0
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
Timepoint [7] 0 0
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Secondary outcome [1] 0 0
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
Timepoint [1] 0 0
From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Secondary outcome [2] 0 0
Percentage of Participants Who Died During the Safety Follow-up Period
Timepoint [2] 0 0
From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
Secondary outcome [3] 0 0
Disease-Free Survival Rate
Timepoint [3] 0 0
From Baseline to time of event (up to approximately 8 years)
Secondary outcome [4] 0 0
Overall Survival Rate
Timepoint [4] 0 0
From Baseline to Time of Event (Up to Approximately 6 Years)
Secondary outcome [5] 0 0
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Timepoint [5] 0 0
Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

Eligibility
Key inclusion criteria
* Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Screening left ventricular ejection fraction (LVEF) greater than or equal to (=) 55%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
* History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
* Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
* Metastatic disease
* Inadequate bone marrow, hepatic, or renal function
* Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* History of severe allergic or immunological reactions, such as difficult-to-control asthma
* Pregnant or lactating women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/02/2020
Sample size
Target
Accrual to date
Final
2577
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Hospital; Cancer Care Centre - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital; Oncology - Randwick
Recruitment hospital [4] 0 0
Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
Recruitment hospital [5] 0 0
Queen Elizabeth Hospital; Medical Oncology - Woodville South
Recruitment hospital [6] 0 0
Western Hospital - Footscray
Recruitment hospital [7] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [8] 0 0
Cabrini Medical Centre; Oncology - Malvern
Recruitment hospital [9] 0 0
Royal Perth Hospital; Department of Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
Country [2] 0 0
Algeria
State/province [2] 0 0
Algiers
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Zarate
Country [5] 0 0
Bosnia and Herzegovina
State/province [5] 0 0
Banja Luka
Country [6] 0 0
Bosnia and Herzegovina
State/province [6] 0 0
Sarajevo
Country [7] 0 0
Brazil
State/province [7] 0 0
BA
Country [8] 0 0
Brazil
State/province [8] 0 0
RS
Country [9] 0 0
Brazil
State/province [9] 0 0
SP
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Plovdiv
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
New Brunswick
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Antofagasta
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
Chile
State/province [19] 0 0
Temuco
Country [20] 0 0
Chile
State/province [20] 0 0
Valparaiso
Country [21] 0 0
Colombia
State/province [21] 0 0
Bogota
Country [22] 0 0
Colombia
State/province [22] 0 0
Cali
Country [23] 0 0
Croatia
State/province [23] 0 0
Osijek
Country [24] 0 0
Croatia
State/province [24] 0 0
Zagreb
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
Country [26] 0 0
Czechia
State/province [26] 0 0
Olomouc
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 5
Country [28] 0 0
Dominican Republic
State/province [28] 0 0
Santiago
Country [29] 0 0
Ecuador
State/province [29] 0 0
Cuenca
Country [30] 0 0
Ecuador
State/province [30] 0 0
Guayaquil
Country [31] 0 0
Ecuador
State/province [31] 0 0
Quito
Country [32] 0 0
Egypt
State/province [32] 0 0
Alexandria
Country [33] 0 0
Egypt
State/province [33] 0 0
Cairo
Country [34] 0 0
El Salvador
State/province [34] 0 0
Salvador
Country [35] 0 0
France
State/province [35] 0 0
Besancon
Country [36] 0 0
France
State/province [36] 0 0
Bordeaux
Country [37] 0 0
France
State/province [37] 0 0
Bourg En Bresse
Country [38] 0 0
France
State/province [38] 0 0
Brest
Country [39] 0 0
France
State/province [39] 0 0
Brive La Gaillarde
Country [40] 0 0
France
State/province [40] 0 0
Chalon Sur Saone
Country [41] 0 0
France
State/province [41] 0 0
Dijon
Country [42] 0 0
France
State/province [42] 0 0
Draguignan
Country [43] 0 0
France
State/province [43] 0 0
Guilherand Granges
Country [44] 0 0
France
State/province [44] 0 0
Hyeres
Country [45] 0 0
France
State/province [45] 0 0
La Roche Sur Yon
Country [46] 0 0
France
State/province [46] 0 0
La Tronche
Country [47] 0 0
France
State/province [47] 0 0
Le Mans
Country [48] 0 0
France
State/province [48] 0 0
LeMans
Country [49] 0 0
France
State/province [49] 0 0
Levallois Perret
Country [50] 0 0
France
State/province [50] 0 0
Lille
Country [51] 0 0
France
State/province [51] 0 0
Lorient
Country [52] 0 0
France
State/province [52] 0 0
Lyon
Country [53] 0 0
France
State/province [53] 0 0
Marseille
Country [54] 0 0
France
State/province [54] 0 0
Metz Tessy
Country [55] 0 0
France
State/province [55] 0 0
Metz
Country [56] 0 0
France
State/province [56] 0 0
Montpellier
Country [57] 0 0
France
State/province [57] 0 0
Mougins
Country [58] 0 0
France
State/province [58] 0 0
Nice
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Pau
Country [61] 0 0
France
State/province [61] 0 0
Pierre Benite
Country [62] 0 0
France
State/province [62] 0 0
Saint Gregoire
Country [63] 0 0
France
State/province [63] 0 0
Saint Herblain
Country [64] 0 0
France
State/province [64] 0 0
Saint Jean
Country [65] 0 0
France
State/province [65] 0 0
Saint Quentin
Country [66] 0 0
France
State/province [66] 0 0
Saint-priest-en-jarez
Country [67] 0 0
France
State/province [67] 0 0
St Martin Boulogne
Country [68] 0 0
France
State/province [68] 0 0
Strasbourg
Country [69] 0 0
France
State/province [69] 0 0
Thonon Les Bains
Country [70] 0 0
France
State/province [70] 0 0
Toulouse
Country [71] 0 0
France
State/province [71] 0 0
Valenciennes
Country [72] 0 0
France
State/province [72] 0 0
Vandoeuvre-les-Nancy
Country [73] 0 0
Germany
State/province [73] 0 0
Augsburg
Country [74] 0 0
Germany
State/province [74] 0 0
Bad Soden
Country [75] 0 0
Germany
State/province [75] 0 0
Berlin
Country [76] 0 0
Germany
State/province [76] 0 0
Bielefeld
Country [77] 0 0
Germany
State/province [77] 0 0
Bochum
Country [78] 0 0
Germany
State/province [78] 0 0
Deggendorf
Country [79] 0 0
Germany
State/province [79] 0 0
Essen
Country [80] 0 0
Germany
State/province [80] 0 0
Freiburg
Country [81] 0 0
Germany
State/province [81] 0 0
Georgsmarienhütte
Country [82] 0 0
Germany
State/province [82] 0 0
Halle
Country [83] 0 0
Germany
State/province [83] 0 0
Hamburg
Country [84] 0 0
Germany
State/province [84] 0 0
Hannover
Country [85] 0 0
Germany
State/province [85] 0 0
Heidelberg
Country [86] 0 0
Germany
State/province [86] 0 0
Jena
Country [87] 0 0
Germany
State/province [87] 0 0
Kassel
Country [88] 0 0
Germany
State/province [88] 0 0
Koeln
Country [89] 0 0
Germany
State/province [89] 0 0
Kulmbach
Country [90] 0 0
Germany
State/province [90] 0 0
Köln
Country [91] 0 0
Germany
State/province [91] 0 0
Langen
Country [92] 0 0
Germany
State/province [92] 0 0
Leverkusen
Country [93] 0 0
Germany
State/province [93] 0 0
Ludwigsburg
Country [94] 0 0
Germany
State/province [94] 0 0
Lübeck
Country [95] 0 0
Germany
State/province [95] 0 0
Mainz
Country [96] 0 0
Germany
State/province [96] 0 0
Marburg
Country [97] 0 0
Germany
State/province [97] 0 0
Meiningen
Country [98] 0 0
Germany
State/province [98] 0 0
Memmingen
Country [99] 0 0
Germany
State/province [99] 0 0
Minden
Country [100] 0 0
Germany
State/province [100] 0 0
Mühlhausen
Country [101] 0 0
Germany
State/province [101] 0 0
München
Country [102] 0 0
Germany
State/province [102] 0 0
Münster
Country [103] 0 0
Germany
State/province [103] 0 0
Neuruppin
Country [104] 0 0
Germany
State/province [104] 0 0
Nürnberg
Country [105] 0 0
Germany
State/province [105] 0 0
Offenbach
Country [106] 0 0
Germany
State/province [106] 0 0
Ostfildern
Country [107] 0 0
Germany
State/province [107] 0 0
Recklinghausen
Country [108] 0 0
Germany
State/province [108] 0 0
Rotenburg/Wümme
Country [109] 0 0
Germany
State/province [109] 0 0
Saarbruecken
Country [110] 0 0
Germany
State/province [110] 0 0
Schweinfurt
Country [111] 0 0
Germany
State/province [111] 0 0
Schwerin
Country [112] 0 0
Germany
State/province [112] 0 0
Stendal
Country [113] 0 0
Germany
State/province [113] 0 0
Torgau
Country [114] 0 0
Germany
State/province [114] 0 0
Tübingen
Country [115] 0 0
Germany
State/province [115] 0 0
Unna
Country [116] 0 0
Germany
State/province [116] 0 0
Weinheim
Country [117] 0 0
Germany
State/province [117] 0 0
Weißenfels
Country [118] 0 0
Germany
State/province [118] 0 0
Wetzlar
Country [119] 0 0
Germany
State/province [119] 0 0
Wuerselen
Country [120] 0 0
Greece
State/province [120] 0 0
Athens
Country [121] 0 0
Greece
State/province [121] 0 0
Heraklion
Country [122] 0 0
Greece
State/province [122] 0 0
Kifisia
Country [123] 0 0
Greece
State/province [123] 0 0
Thessaloniki
Country [124] 0 0
Greece
State/province [124] 0 0
??e?a?d???p???
Country [125] 0 0
Greece
State/province [125] 0 0
?a??sa
Country [126] 0 0
Guatemala
State/province [126] 0 0
Guatemala City
Country [127] 0 0
Guatemala
State/province [127] 0 0
Guatemala
Country [128] 0 0
Hong Kong
State/province [128] 0 0
Hong Kong
Country [129] 0 0
Hong Kong
State/province [129] 0 0
Shatin
Country [130] 0 0
Hungary
State/province [130] 0 0
Budapest
Country [131] 0 0
Hungary
State/province [131] 0 0
Debrecen
Country [132] 0 0
Hungary
State/province [132] 0 0
Nyíregyháza
Country [133] 0 0
Hungary
State/province [133] 0 0
Pécs
Country [134] 0 0
Hungary
State/province [134] 0 0
Szombathely
Country [135] 0 0
Indonesia
State/province [135] 0 0
Bandung
Country [136] 0 0
Indonesia
State/province [136] 0 0
Central Jakarta
Country [137] 0 0
Indonesia
State/province [137] 0 0
East Java
Country [138] 0 0
Indonesia
State/province [138] 0 0
Jakarta
Country [139] 0 0
Indonesia
State/province [139] 0 0
Jogjakarta
Country [140] 0 0
Ireland
State/province [140] 0 0
Dublin
Country [141] 0 0
Ireland
State/province [141] 0 0
Limerick City
Country [142] 0 0
Ireland
State/province [142] 0 0
Sligo
Country [143] 0 0
Ireland
State/province [143] 0 0
Waterford
Country [144] 0 0
Italy
State/province [144] 0 0
Basilicata
Country [145] 0 0
Italy
State/province [145] 0 0
Campania
Country [146] 0 0
Italy
State/province [146] 0 0
Emilia-Romagna
Country [147] 0 0
Italy
State/province [147] 0 0
Lazio
Country [148] 0 0
Italy
State/province [148] 0 0
Lombardia
Country [149] 0 0
Italy
State/province [149] 0 0
Piemonte
Country [150] 0 0
Italy
State/province [150] 0 0
Puglia
Country [151] 0 0
Italy
State/province [151] 0 0
Sardegna
Country [152] 0 0
Italy
State/province [152] 0 0
Sicilia
Country [153] 0 0
Italy
State/province [153] 0 0
Toscana
Country [154] 0 0
Italy
State/province [154] 0 0
Veneto
Country [155] 0 0
Korea, Republic of
State/province [155] 0 0
Goyang-si
Country [156] 0 0
Korea, Republic of
State/province [156] 0 0
Seoul
Country [157] 0 0
Lithuania
State/province [157] 0 0
Kaunas
Country [158] 0 0
Lithuania
State/province [158] 0 0
Klaipeda
Country [159] 0 0
Malaysia
State/province [159] 0 0
Georgetown
Country [160] 0 0
Malaysia
State/province [160] 0 0
Kuala Lumpur
Country [161] 0 0
Malaysia
State/province [161] 0 0
Sabah
Country [162] 0 0
Malaysia
State/province [162] 0 0
Sarawak
Country [163] 0 0
Mexico
State/province [163] 0 0
Campeche
Country [164] 0 0
Mexico
State/province [164] 0 0
Chihuahua
Country [165] 0 0
Mexico
State/province [165] 0 0
Distrito Federal
Country [166] 0 0
Mexico
State/province [166] 0 0
Mexico City
Country [167] 0 0
Mexico
State/province [167] 0 0
Oaxaca
Country [168] 0 0
Mexico
State/province [168] 0 0
Queretaro, Queretaro
Country [169] 0 0
Mexico
State/province [169] 0 0
Tepic
Country [170] 0 0
Morocco
State/province [170] 0 0
Rabat
Country [171] 0 0
Netherlands
State/province [171] 0 0
'S Hertogenbosch
Country [172] 0 0
Netherlands
State/province [172] 0 0
AC Amsterdam
Country [173] 0 0
Netherlands
State/province [173] 0 0
Apeldoorn
Country [174] 0 0
Netherlands
State/province [174] 0 0
Arnhem
Country [175] 0 0
Netherlands
State/province [175] 0 0
Dordrecht
Country [176] 0 0
Netherlands
State/province [176] 0 0
EDE
Country [177] 0 0
Netherlands
State/province [177] 0 0
Eindhoven
Country [178] 0 0
Netherlands
State/province [178] 0 0
Groningen
Country [179] 0 0
Netherlands
State/province [179] 0 0
Heerlen
Country [180] 0 0
Netherlands
State/province [180] 0 0
Hoofddorp
Country [181] 0 0
Netherlands
State/province [181] 0 0
Nieuwegein
Country [182] 0 0
Netherlands
State/province [182] 0 0
Roosendaal
Country [183] 0 0
Netherlands
State/province [183] 0 0
Rotterdam
Country [184] 0 0
Netherlands
State/province [184] 0 0
Schiedam
Country [185] 0 0
Netherlands
State/province [185] 0 0
Sittard-Geleen
Country [186] 0 0
Netherlands
State/province [186] 0 0
Utrecht
Country [187] 0 0
Netherlands
State/province [187] 0 0
Venlo
Country [188] 0 0
Netherlands
State/province [188] 0 0
Zaandam
Country [189] 0 0
New Zealand
State/province [189] 0 0
Tauranga
Country [190] 0 0
Norway
State/province [190] 0 0
Kristiansand
Country [191] 0 0
Norway
State/province [191] 0 0
Oslo
Country [192] 0 0
Norway
State/province [192] 0 0
Stavanger
Country [193] 0 0
Pakistan
State/province [193] 0 0
Islamabad
Country [194] 0 0
Pakistan
State/province [194] 0 0
Karachi
Country [195] 0 0
Pakistan
State/province [195] 0 0
Lahore
Country [196] 0 0
Panama
State/province [196] 0 0
Panama
Country [197] 0 0
Peru
State/province [197] 0 0
Arequipa
Country [198] 0 0
Peru
State/province [198] 0 0
Lima
Country [199] 0 0
Peru
State/province [199] 0 0
LIma
Country [200] 0 0
Philippines
State/province [200] 0 0
Manila
Country [201] 0 0
Philippines
State/province [201] 0 0
Quezon City
Country [202] 0 0
Poland
State/province [202] 0 0
Kraków
Country [203] 0 0
Poland
State/province [203] 0 0
Otwock
Country [204] 0 0
Poland
State/province [204] 0 0
Poznan
Country [205] 0 0
Poland
State/province [205] 0 0
Rzeszow
Country [206] 0 0
Poland
State/province [206] 0 0
Torun
Country [207] 0 0
Poland
State/province [207] 0 0
Zory
Country [208] 0 0
Portugal
State/province [208] 0 0
Lisboa
Country [209] 0 0
Portugal
State/province [209] 0 0
Porto
Country [210] 0 0
Romania
State/province [210] 0 0
Baia Mare
Country [211] 0 0
Romania
State/province [211] 0 0
Bucharest
Country [212] 0 0
Romania
State/province [212] 0 0
Bucuresti
Country [213] 0 0
Romania
State/province [213] 0 0
Cluj Napoca
Country [214] 0 0
Romania
State/province [214] 0 0
Cluj-Napoca
Country [215] 0 0
Romania
State/province [215] 0 0
Craiova
Country [216] 0 0
Romania
State/province [216] 0 0
Timisoara
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Irkutsk
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Izhevsk
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Moscow
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Orenburg
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Saint-Petersburg
Country [222] 0 0
Russian Federation
State/province [222] 0 0
UFA
Country [223] 0 0
Saudi Arabia
State/province [223] 0 0
Jeddah
Country [224] 0 0
Saudi Arabia
State/province [224] 0 0
Riyadh
Country [225] 0 0
Serbia
State/province [225] 0 0
Belgrade
Country [226] 0 0
Serbia
State/province [226] 0 0
Kragujevac
Country [227] 0 0
Serbia
State/province [227] 0 0
Nis
Country [228] 0 0
Serbia
State/province [228] 0 0
Sremska Kamenica
Country [229] 0 0
Singapore
State/province [229] 0 0
Singapore
Country [230] 0 0
Slovakia
State/province [230] 0 0
Banská Bystrica
Country [231] 0 0
Slovakia
State/province [231] 0 0
Bratislava
Country [232] 0 0
Slovakia
State/province [232] 0 0
Košice
Country [233] 0 0
Slovakia
State/province [233] 0 0
Presov
Country [234] 0 0
Slovakia
State/province [234] 0 0
Trencin
Country [235] 0 0
Slovenia
State/province [235] 0 0
Maribor
Country [236] 0 0
South Africa
State/province [236] 0 0
Durban
Country [237] 0 0
South Africa
State/province [237] 0 0
Johannesburg
Country [238] 0 0
South Africa
State/province [238] 0 0
Pretoria
Country [239] 0 0
Spain
State/province [239] 0 0
Alicante
Country [240] 0 0
Spain
State/province [240] 0 0
Asturias
Country [241] 0 0
Spain
State/province [241] 0 0
Barcelona
Country [242] 0 0
Spain
State/province [242] 0 0
Cantabria
Country [243] 0 0
Spain
State/province [243] 0 0
Guipuzcoa
Country [244] 0 0
Spain
State/province [244] 0 0
Islas Baleares
Country [245] 0 0
Spain
State/province [245] 0 0
LAS Palmas
Country [246] 0 0
Spain
State/province [246] 0 0
Madrid
Country [247] 0 0
Spain
State/province [247] 0 0
Pontevedra
Country [248] 0 0
Spain
State/province [248] 0 0
Tenerife
Country [249] 0 0
Spain
State/province [249] 0 0
Valencia
Country [250] 0 0
Spain
State/province [250] 0 0
Vizcaya
Country [251] 0 0
Spain
State/province [251] 0 0
Albacete
Country [252] 0 0
Spain
State/province [252] 0 0
Burgos
Country [253] 0 0
Spain
State/province [253] 0 0
Caceres
Country [254] 0 0
Spain
State/province [254] 0 0
Jaen
Country [255] 0 0
Spain
State/province [255] 0 0
Leon
Country [256] 0 0
Spain
State/province [256] 0 0
Lerida
Country [257] 0 0
Spain
State/province [257] 0 0
Murcia
Country [258] 0 0
Spain
State/province [258] 0 0
Navarra
Country [259] 0 0
Spain
State/province [259] 0 0
Toledo
Country [260] 0 0
Spain
State/province [260] 0 0
Zaragoza
Country [261] 0 0
Sweden
State/province [261] 0 0
Lund
Country [262] 0 0
Sweden
State/province [262] 0 0
Skoevde
Country [263] 0 0
Switzerland
State/province [263] 0 0
Aarau
Country [264] 0 0
Switzerland
State/province [264] 0 0
Baden
Country [265] 0 0
Switzerland
State/province [265] 0 0
Bellinzona
Country [266] 0 0
Switzerland
State/province [266] 0 0
Bern
Country [267] 0 0
Switzerland
State/province [267] 0 0
Frauenfeld
Country [268] 0 0
Switzerland
State/province [268] 0 0
Lausanne
Country [269] 0 0
Switzerland
State/province [269] 0 0
Thun
Country [270] 0 0
Switzerland
State/province [270] 0 0
Winterthur
Country [271] 0 0
Switzerland
State/province [271] 0 0
Zürich
Country [272] 0 0
Taiwan
State/province [272] 0 0
Taichung
Country [273] 0 0
Taiwan
State/province [273] 0 0
Tainan
Country [274] 0 0
Taiwan
State/province [274] 0 0
Taipei
Country [275] 0 0
Thailand
State/province [275] 0 0
Bangkok
Country [276] 0 0
Thailand
State/province [276] 0 0
Chiang Mai
Country [277] 0 0
Thailand
State/province [277] 0 0
Dusit
Country [278] 0 0
Turkey
State/province [278] 0 0
Ankara
Country [279] 0 0
Turkey
State/province [279] 0 0
Antalya
Country [280] 0 0
Turkey
State/province [280] 0 0
Diyarbakir
Country [281] 0 0
Turkey
State/province [281] 0 0
Gaziantep
Country [282] 0 0
Turkey
State/province [282] 0 0
Istanbul
Country [283] 0 0
Turkey
State/province [283] 0 0
Izmit
Country [284] 0 0
Turkey
State/province [284] 0 0
Mersin
Country [285] 0 0
Turkey
State/province [285] 0 0
Samsun
Country [286] 0 0
Turkey
State/province [286] 0 0
Sihhiye/Ankara
Country [287] 0 0
Ukraine
State/province [287] 0 0
Kiev
Country [288] 0 0
Ukraine
State/province [288] 0 0
Lviv
Country [289] 0 0
United Arab Emirates
State/province [289] 0 0
Al Ain
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Abergavenny
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Bedford
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Berkshire
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Birmingham
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Bournemouth
Country [295] 0 0
United Kingdom
State/province [295] 0 0
Canterbury
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Chelmsford
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Denbighshire
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Derby
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Devon
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Dudley
Country [301] 0 0
United Kingdom
State/province [301] 0 0
Durham
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Glasgow
Country [303] 0 0
United Kingdom
State/province [303] 0 0
Greenock
Country [304] 0 0
United Kingdom
State/province [304] 0 0
Grimsby
Country [305] 0 0
United Kingdom
State/province [305] 0 0
Guildford
Country [306] 0 0
United Kingdom
State/province [306] 0 0
Harlow
Country [307] 0 0
United Kingdom
State/province [307] 0 0
Huddersfield
Country [308] 0 0
United Kingdom
State/province [308] 0 0
Ipswich
Country [309] 0 0
United Kingdom
State/province [309] 0 0
Kilmarnock
Country [310] 0 0
United Kingdom
State/province [310] 0 0
Larbert
Country [311] 0 0
United Kingdom
State/province [311] 0 0
Leicester
Country [312] 0 0
United Kingdom
State/province [312] 0 0
Livingston
Country [313] 0 0
United Kingdom
State/province [313] 0 0
London
Country [314] 0 0
United Kingdom
State/province [314] 0 0
Macclesfield
Country [315] 0 0
United Kingdom
State/province [315] 0 0
Manchester
Country [316] 0 0
United Kingdom
State/province [316] 0 0
New Castle Upon Tyne
Country [317] 0 0
United Kingdom
State/province [317] 0 0
Newport
Country [318] 0 0
United Kingdom
State/province [318] 0 0
North Shields
Country [319] 0 0
United Kingdom
State/province [319] 0 0
Northampton
Country [320] 0 0
United Kingdom
State/province [320] 0 0
Plymouth
Country [321] 0 0
United Kingdom
State/province [321] 0 0
Poole
Country [322] 0 0
United Kingdom
State/province [322] 0 0
Portsmouth
Country [323] 0 0
United Kingdom
State/province [323] 0 0
Preston
Country [324] 0 0
United Kingdom
State/province [324] 0 0
Romford
Country [325] 0 0
United Kingdom
State/province [325] 0 0
Scarborough
Country [326] 0 0
United Kingdom
State/province [326] 0 0
Shrewsbury
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Southampton
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Sunderland
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Swansea
Country [330] 0 0
United Kingdom
State/province [330] 0 0
Swindon
Country [331] 0 0
United Kingdom
State/province [331] 0 0
Truro
Country [332] 0 0
United Kingdom
State/province [332] 0 0
Winchester
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Wirral
Country [334] 0 0
United Kingdom
State/province [334] 0 0
Wolverhampton
Country [335] 0 0
United Kingdom
State/province [335] 0 0
York
Country [336] 0 0
Uruguay
State/province [336] 0 0
Montevideo
Country [337] 0 0
Venezuela
State/province [337] 0 0
Caracas
Country [338] 0 0
Vietnam
State/province [338] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01566721