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    Clinical Trial Results:
    Estudio de pemetrexed y cisplatino como tratamiento de primera línea en pacientes con cáncer de pulmón no escamoso, avanzado: estudio farmacogenómico en fase IIA (Study of pemetrexed disodium plus cisplatin as first-line therapy in patients with advanced non-squamous cell lung cancer: a phase IIA pharmacogenomic tria)

    Summary
    EudraCT number
    		 2009-011327-31
    Trial protocol
    		 ES  
    Global end of trial date
    26 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2020
    First version publication date
    15 Jul 2020
    Other versions
    Summary report(s)
    		 GECP_PHALCIS_final report_summary

    Trial information

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    Trial identification
    Sponsor protocol code
    GECP0901PHALCIS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01088906
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grupo Español de Cáncer de Pulmón
    Sponsor organisation address
    Avenida Meridiana 358, 6ª planta, Barcelona, Spain, 08027
    Public contact
    Eva Pereira Álvarez epereira@gecp.org, Grupo Español de Cáncer de Pulmón, 93 4302006, epereira@gecp.org
    Scientific contact
    Dr. Jose Miguel Sánchez Torres, Grupo Español de Cáncer de Pulmón, 93 4302006, epereira@gecp.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Valorar la eficacia de la combinación de pemetrexed y cisplatino como tratamiento de primera línea en apcientes con CPNM avanzado no escamoso To assess the efficacy of the combination of pemetrexed and cisplatin as first-line treatment in patients with advanced non-squamous NSCLC.
    Protection of trial subjects
    Las mujeres en edad fértil incluidas en el estudio deberán tener una prueba de embarazo negativa en los 3 días previos al inicio del estudio. Tanto hombres como mujeres bajo esta condición deberán tomar medidas anticonceptivas durante el estudio y en los 3 meses siguientes a la última dosis del medicamento en estudio. Women of childbearing age included in the study should have proof of negative pregnancy in the 3 days prior to the start of the study. Both men as women under this condition they must take contraceptive measures during the study and in the 3 months following the last dose of study medication.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 Jan 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    42
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Dates of recruitment: start date :20/ 01/2010; ended 19/02/2014 All the patient were recruited in Spain

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Arm of study
    Arm description
    		 Pemetrexed 500 mg / m2 IV will be administered as a 10-minute infusion on day 1 of each cycle. The cycles will last 21 days. For cisplatin the recommended dose is 75 mg / m2 in IV infusion for 2 hours. It will be administered approximately 30 minutes after pemetrexed, on day 1 of each cycle. Patients will continue the study treatment until completing a maximum of 6 cycles or until disease progression, onset of toxicity unacceptable, rejection by the patient or delay in the administration of the treatment> 3 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed 500 mg / m2 IV will be administered as a 10-minute infusion on day 1 of each cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin the recommended dose is 75 mg / m2 in IV infusion for 2 hours. It will be administered approximately 30 minutes after pemetrexed, on day 1 of each cycle.

    Number of subjects in period 1
    		Arm of study
    Started
    52
    Completed
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 NSCLC patients non squamous stages IIIb and IV

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 52 52
    Age categorical
    Female and male
    Units: Subjects
        Adults (18-64 years)
    		 42 42
        From 65-84 years
    		 10 10
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (53 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 39 39
    Smoking status
    Units: Subjects
        Never
    		 5 5
        Former
    		 31 31
        Smoker
    		 16 16
    ECOG
    Units: Subjects
        ECOG 0
    		 5 14
        ECOG 1
    		 33 33
        ECOG UK
    		 5 5
    Histology
    Units: Subjects
        Adenocarcinoma
    		 51 51
        Large Cell Lung Carcinoma
    		 1 1
    Treatment compliance
    Units: Subjects
        C1
    		 1 1
        C2
    		 7 7
        C3
    		 6 6
        C4
    		 8 8
        C5
    		 4 4
        C6
    		 26 26
    Subject analysis sets

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    NSCLC non squamous stage IIb and IV

    Subject analysis sets values
    		 Final analysis
    Number of subjects
    52
    Age categorical
    Female and male
    Units: Subjects
        Adults (18-64 years)
    42
        From 65-84 years
    10
    Age continuous
    Units: years
        median (full range (min-max))
    62 (53 to 72)
    Gender categorical
    Units: Subjects
        Female
    13
        Male
    39
    Smoking status
    Units: Subjects
        Never
    5
        Former
    31
        Smoker
    16
    ECOG
    Units: Subjects
        ECOG 0
    14
        ECOG 1
    33
        ECOG UK
    5
    Histology
    Units: Subjects
        Adenocarcinoma
    51
        Large Cell Lung Carcinoma
    1
    Treatment compliance
    Units: Subjects
        C1
    1
        C2
    7
        C3
    6
        C4
    8
        C5
    4
        C6
    26

    End points

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    End points reporting groups
    Reporting group title
    Arm of study
    Reporting group description
    		 Pemetrexed 500 mg / m2 IV will be administered as a 10-minute infusion on day 1 of each cycle. The cycles will last 21 days. For cisplatin the recommended dose is 75 mg / m2 in IV infusion for 2 hours. It will be administered approximately 30 minutes after pemetrexed, on day 1 of each cycle. Patients will continue the study treatment until completing a maximum of 6 cycles or until disease progression, onset of toxicity unacceptable, rejection by the patient or delay in the administration of the treatment> 3 weeks.

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    NSCLC non squamous stage IIb and IV

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    The percentage of patients who have experienced a tumor response since the start of treatment The percentage of patients who have experienced tumor regression since the start of treatment (Complete response + Partial response) among the total of patients ORR = 34% Disease control rate (Complete response + Partial Response + Stable Disease) = 78% ORR: (%) Stable disease:44 Partial response:22 Complete response:4 Progression:30
    End point type
    Primary
    End point timeframe
    At the end of study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point. Conclusion : The combination of pemetrexed and cisplatin as first-line treatment in patients with Stage IV non-small cell lung cancer achieves a 34% response rate (complete response in 4.0% and partial response in 30%), and a control rate of 78% disease. The median progression-free survival was 5.63 months, and 11.27 months in overall survival. No significant differences were found in PFS or OS according to expression of the BRCA1, RAP80 or TS genes
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: subjects
        Stable disease
    22
    22
        Partial response
    12
    12
        Complete response
    2
    2
        Progression
    16
    16
    No statistical analyses for this end point

    Secondary: Time to progression

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    End point title
    		 Time to progression
    End point description
    This interval is measured in months from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.
    End point type
    Secondary
    End point timeframe
    At the end of study
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
        median (confidence interval 95%)
    5.633 (4.180 to 7.087)
    5.633 (4.180 to 7.087)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival is measured from the date of enrollment to the date of death from any cause
    End point type
    Secondary
    End point timeframe
    At the end of study.
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
        median (confidence interval 95%)
    11.267 (9.141 to 13.392)
    11.267 (9.141 to 13.392)
    No statistical analyses for this end point

    Secondary: Biomarker BRCA1_Time to progression

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    End point title
    		 Biomarker BRCA1_Time to progression
    End point description
    This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.
    End point type
    Secondary
    End point timeframe
    At the end of study
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    Units: Months
    median (confidence interval 95%)
        BRCA1 negative
    5.270 (3.443 to 7.097)
    5.270 (3.443 to 7.097)
        BRCA1 positive
    3.430 (0.564 to 6.296)
    3.430 (0.564 to 6.296)
        Global
    5.270 (2.678 to 7.862)
    5.270 (2.678 to 7.862)
    No statistical analyses for this end point

    Secondary: Biomarker RAP80_Time to progression

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    End point title
    		 Biomarker RAP80_Time to progression
    End point description
    This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.
    End point type
    Secondary
    End point timeframe
    At the end of study.
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
    median (confidence interval 95%)
        RAP80 negative
    5.630 (2.416 to 8.844)
    5.630 (2.416 to 8.844)
        RAP80 positive
    3.430 (0.0 to 7.354)
    3.430 (0.0 to 7.354)
        Global
    5.370 (2.430 to 8.310)
    5.370 (2.430 to 8.310)
    No statistical analyses for this end point

    Secondary: Biomarker TS_Time to progression

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    End point title
    		 Biomarker TS_Time to progression
    End point description
    This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.
    End point type
    Secondary
    End point timeframe
    At the end of study
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
    median (confidence interval 95%)
        TS negative
    5.630 (0.249 to 11.011)
    5.630 (0.249 to 11.011)
        TS positive
    3.330 (2.590 to 4.070)
    3.330 (2.590 to 4.070)
        Global
    3.430 (1.738 to 5.122)
    3.430 (1.738 to 5.122)
    No statistical analyses for this end point

    Secondary: Biomarker BRCA1_Overall survival

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    End point title
    		 Biomarker BRCA1_Overall survival
    End point description
    Overall survival is measured from the date of enrollment to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    At the end of study.
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
    median (confidence interval 95%)
        BRCA1 negative
    12.270 (7.605 to 16.935)
    12.270 (7.605 to 16.935)
        BRCA1 positive
    8.400 (0.864 to 15.936)
    8.400 (0.864 to 15.936)
        Global
    10.570 (6.921 to 14.219)
    10.570 (6.921 to 14.219)
    No statistical analyses for this end point

    Secondary: Biomarker RAP80_ Overall survival

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    End point title
    		 Biomarker RAP80_ Overall survival
    End point description
    Overall survival is measured from the date of enrollment to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    At the end of study.
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
    median (confidence interval 95%)
        RAP80 negative
    10.570 (0.00 to 24.843)
    10.570 (0.00 to 24.843)
        RAP80 positive
    9.600 (4.787 to 14.413)
    9.600 (4.787 to 14.413)
        Global
    10.570 (5.865 to 15.275)
    10.570 (5.865 to 15.275)
    No statistical analyses for this end point

    Secondary: Biomarker TS_ Overall Survival

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    End point title
    		 Biomarker TS_ Overall Survival
    End point description
    Overall survival is measured from the date of enrollment to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    At the end of study.
    End point values
    		 Arm of study Final analysis
    Number of subjects analysed
    52
    52
    Units: Months
    median (confidence interval 95%)
        TS negative
    12.270 (2.136 to 22.404)
    12.270 (2.136 to 22.404)
        TS positivie
    8.400 (0.473 to 16.327)
    8.400 (0.473 to 16.327)
        Global
    11.270 (5.351 to 17.189)
    11.270 (5.351 to 17.189)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV).
    Adverse event reporting additional description
    Common terminology criteria for adverse events was used in this study (NCI CTCAE version 3.0). Consistent with EudraCT disclosure specifications, GECP has reported under the SAE field “number of deaths resulting from AE” 0 deaths, because there are not deemed to be causally related to treatment by the investigator. In total were 9 exitus.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Subjects per protocol
    Reporting group description
    		 -

    Serious adverse events
    		 Subjects per protocol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 52 (48.08%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Lower member embolism
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stroke ischemic and pneumonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute ischemia of lower limbs
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pulmonary thromboembolism
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Disorientation and loss motor control
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Hemoglobin
    Additional description: Grade III
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukocytes (total WBC)
    Additional description: Grade III
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutrophils/granulocytes (ANC/AGC)
    Additional description: Grade III
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
    Additional description: Grade III
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyporexia
    Additional description: grade III
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea and vomiting
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
    Additional description: Poorly controlled pain
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Anorexy
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Mucositis
    Additional description: grade III
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhea and fever
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal bleeding
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: Grade III
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Impaired function renal
    Additional description: Grade III
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary infection
    Additional description: Before starting chemotherapy
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Oliguria
    Additional description: Swelling abdominal and face.
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    General stiffness
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
    Additional description: Grade III
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bilateral bronchopneumonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Subjects per protocol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 52 (76.92%)
    Nervous system disorders
    Neurotoxicity sensitive
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    8
    Blood and lymphatic system disorders
    Haemoglobin
         subjects affected / exposed
    40 / 52 (76.92%)
         occurrences all number
    40
    Leukocytes
         subjects affected / exposed
    20 / 52 (38.46%)
         occurrences all number
    20
    Neutrophils
         subjects affected / exposed
    14 / 52 (26.92%)
         occurrences all number
    14
    Platelets
         subjects affected / exposed
    6 / 52 (11.54%)
         occurrences all number
    6
    Edema
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Febrile neutropenia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    35 / 52 (67.31%)
         occurrences all number
    35
    Fever
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ototoxicity
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences all number
    7
    Dysgeusia
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    13 / 52 (25.00%)
         occurrences all number
    13
    Mucositis
         subjects affected / exposed
    12 / 52 (23.08%)
         occurrences all number
    12
    Nausea-vomiting
         subjects affected / exposed
    40 / 52 (76.92%)
         occurrences all number
    40
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Renal and urinary disorders
    Impaired function renal
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Endocrine disorders
    Increase AST/ALT
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    Hyporexia
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences all number
    7
    Increase GGT
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    8
    Hyperglycemia
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    8
    Hyperkalemia
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Hyponatremia
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    LDH increase
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 Feb 2014
    This study had a premature discontinuation due to the low recruitment rate of the study, not for safety reasons of the participants.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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