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    Clinical Trial Results:
    Open-label, multicenter, pilot-trial evaluating the safety and utility of a hybrid decentralized clinical trial (DCT) approach using a TELEmedicine platform in patients with HR-positive/HER2-negative advanced breast cancer with a PIK3CA mutation treated with alpelisib – fulvestrant TELEPIK Trial

    Summary
    EudraCT number
    		 2020-005882-15
    Trial protocol
    		 SE  
    Global end of trial date
    19 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2023
    First version publication date
    07 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBYL719A03201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04862143
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    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
    19 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to assess participant satisfaction with the decentralized clinical trial (DCT) experience.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2022
    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
    Sweden: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 1 center from Sweden

    Pre-assignment
    Screening details
    		 The screening phase began once written informed consent was provided and ended after 28 days or when subject was enrolled, whichever came first.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Alpelisib + fulvestrant
    Arm description
    		 Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alpelisib
    Investigational medicinal product code
    BYL719
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a daily oral dose of 300 mg of alpelisib film-coated tablets for a total of 12 cycles, with each cycle lasting 28 days.

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and on Day 1 of each 28-day cycle thereafter until Cycle 12.

    Investigational medicinal product name
    Goserelin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pre-menopausal women were administered a dose of 3.6 mg of goserelin injection via intramuscular route, beginning on Cycle 1 Day 1. Subsequently, the same dose was administered on Day 1 of each 28-day cycle throughout the study.

    Number of subjects in period 1
    		Alpelisib + fulvestrant
    Started
    2
    Completed
    0
    Not completed
    2
         Adverse event, non-fatal
    1
         Study terminated by sponsor
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alpelisib + fulvestrant
    Reporting group description
    		 Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.

    Reporting group values
    		 Alpelisib + fulvestrant Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 54 ( 0 ) -
    Sex/Gender, Customized
    Gender details were not collected from any participant
    Units: Participants
        Unknown
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Alpelisib + fulvestrant
    Reporting group description
    		 Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.

    Primary: Participant satisfaction assessed through the trial feedback questionnaire (TFQ)

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    End point title
    		 Participant satisfaction assessed through the trial feedback questionnaire (TFQ) [1]
    End point description
    The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score). "9999" values indicate that there was not sufficient data available to calculate the value.
    End point type
    Primary
    End point timeframe
    Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days
    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 were conducted for the primary endpoint
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Score on a Scale
    median (full range (min-max))
        Baseline (n=2)
    99.5 (92 to 107)
        Cycle 4 Day 1 (n=1)
    89 (-9999 to 9999)
        Cycle 7 Day 1 (n=1)
    98 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Patient retention on the decentralized clinical trial (DCT) approach

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    End point title
    		 Patient retention on the decentralized clinical trial (DCT) approach
    End point description
    Patient retention on the DCT approach was calculated as the percentage of participants on remote monitoring for participants still on treatment
    End point type
    Secondary
    End point timeframe
    At 3 and 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    1
    Units: Participants
        3 months
    1
        6 months
    1
    No statistical analyses for this end point

    Secondary: Number of unscheduled in-clinic visits per participant in the study

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    End point title
    		 Number of unscheduled in-clinic visits per participant in the study
    End point description
    Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits per participants was evaluated
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of study, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Visits per participant
    0
    No statistical analyses for this end point

    Secondary: Number of participants who discontinue treatment due to adverse events (AEs)

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    End point title
    		 Number of participants who discontinue treatment due to adverse events (AEs)
    End point description
    An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants who discontinued the treatment due to adverse events was evaluated
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of treatment, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Participants
    1
    No statistical analyses for this end point

    Secondary: Number of unscheduled in-clinic visits because of safety reasons

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    End point title
    		 Number of unscheduled in-clinic visits because of safety reasons
    End point description
    Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits that were prompted by safety reasons was evaluated
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of study, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Visits
    0
    No statistical analyses for this end point

    Secondary: Number of unscheduled in-clinic visits

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    End point title
    		 Number of unscheduled in-clinic visits
    End point description
    Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits was evaluated
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of study, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Visits
    0
    No statistical analyses for this end point

    Secondary: Number of participants with dose reductions/interruptions for alpelisib

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    End point title
    		 Number of participants with dose reductions/interruptions for alpelisib
    End point description
    Number of participants with dose reductions and interruptions for alpelisib
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of treatment, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Participants
        Dose interruptions
    1
        Dose reductions
    1
    No statistical analyses for this end point

    Secondary: Number of participants with Adverse events of special interest (AESIs)- hyperglicemia, rash and diarrhea

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    End point title
    		 Number of participants with Adverse events of special interest (AESIs)- hyperglicemia, rash and diarrhea
    End point description
    AESIs (Adverse Events of Special Interest) are defined as events, whether serious or non-serious, that are of scientific and medical concern specific to the sponsor's product or program. These events may require ongoing monitoring and communication by the investigator to the sponsor. For this study, the following AESIs were defined: hyperglycemia, rash, and diarrhea. The number of participants experiencing these events per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 was evaluated.
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of study, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Participants
        Diarrhea
    1
        Hyperglycaemia
    2
        Rash
    0
    No statistical analyses for this end point

    Secondary: Number of participants with Adverse Events (AEs) leading to in-clinic visits

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    End point title
    		 Number of participants with Adverse Events (AEs) leading to in-clinic visits
    End point description
    An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants with AEs per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 leading to in-clinic visits was assessed.
    End point type
    Secondary
    End point timeframe
    From the date of the first study treatment up to the end of study, assessed up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

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    End point title
    		 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    End point description
    The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale. All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. The EORTC QLQ-C30 scores for all functional and symptom scales were evaluated. "9999" values indicate that there was not sufficient data available to calculate the value.
    End point type
    Secondary
    End point timeframe
    Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Score on a Scale
    median (full range (min-max))
        QoL- Baseline (n=2)
    75 (67 to 83)
        QoL- Cycle 4 Day 1 (n=1)
    83 (-9999 to 9999)
        QoL- Cycle 7 Day 1 (n=1)
    92 (-9999 to 9999)
        QoL- End of Treatment (n=2)
    75 (67 to 83)
        Physical Functioning- Baseline (n=2)
    90 (80 to 100)
        Physical Functioning- Cycle 4 Day 1 (n=1)
    93 (-9999 to 9999)
        Physical Functioning- Cycle 7 Day 1 (n=1)
    100 (-9999 to 9999)
        Physical Functioning-End of Treatment (n=2)
    86.5 (80 to 93)
        Role Functioning- Baseline (n=2)
    91.5 (83 to 100)
        Role Functioning- Cycle 4 Day 1 (n=1)
    100 (-9999 to 9999)
        Role Functioning- Cycle 7 Day 1 (n=1)
    100 (-9999 to 9999)
        Role Functioning-End of Treatment (n=2)
    83.5 (67 to 100)
        Emotional Functioning- Baseline (n=2)
    71 (67 to 75)
        Emotional Functioning- Cycle 4 Day 1 (n=1)
    83 (-9999 to 9999)
        Emotional Functioning- Cycle 7 Day 1 (n=1)
    92 (-9999 to 9999)
        Emotional Functioning- End of treatment (n=2)
    83 (83 to 83)
        Cognitive Functioning- Baseline (n=2)
    91.5 (83 to 100)
        Cognitive Functioning- Cycle 4 Day 1 (n=1)
    100 (-9999 to 9999)
        Cognitive Functioning- Cycle 7 Day 1 (n=1)
    100 (-9999 to 9999)
        Cognitive Functioning- End of treatment (n=2)
    75 (67 to 83)
        Social Functioning- Baseline (n=2)
    91.5 (83 to 100)
        Social Functioning- Cycle 4 Day 1 (n=1)
    100 (-9999 to 9999)
        Social Functioning- Cycle 7 Day 1 (n=1)
    100 (-9999 to 9999)
        Social Functioning- End of treatment (n=2)
    91.5 (83 to 100)
        Fatigue- Baseline (n=2)
    22 (0 to 44)
        Fatigue- Cycle 4 Day 1 (n=1)
    22 (-9999 to 9999)
        Fatigue- Cycle 7 Day 1 (n=1)
    0 (-9999 to 9999)
        Fatigue- End of treatment (n=2)
    33 (22 to 44)
        Nausea/vomiting- Baseline (n=2)
    0 (0 to 0)
        Nausea/vomiting- Cycle 4 Day 1 (n=1)
    17 (-9999 to 9999)
        Nausea/vomiting- Cycle 7 Day 1 (n=1)
    0 (-9999 to 9999)
        Nausea/vomiting- End of treatment (n=2)
    0 (0 to 0)
        Pain- Baseline (n=2)
    8.5 (0 to 17)
        Pain- Cycle 4 Day 1 (n=1)
    0 (-9999 to 9999)
        Pain- Cycle 7 Day 1 (n=1)
    0 (-9999 to 9999)
        Pain- End of treatment (n=2)
    16.5 (0 to 33)
    No statistical analyses for this end point

    Secondary: EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual analog scale (VAS) score

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    End point title
    		 EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual analog scale (VAS) score
    End point description
    The 5-level EQ-5D (EQ-5D-5L) questionnaire is a standardized measure of health status. The EQ-5D descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The EQ-5D-5L VAS scores were evaluated. "9999" values indicate that there was not sufficient data available to calculate the value.
    End point type
    Secondary
    End point timeframe
    Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Score on a scale
    median (full range (min-max))
        Baseline (n=2)
    80 (75 to 85)
        Cycle 4 Day 1 (n=1)
    93 (-9999 to 9999)
        Cycle 7 Day 1 (n=1)
    95 (-9999 to 9999)
        End of treatment (n=2)
    82.5 (70 to 95)
    No statistical analyses for this end point

    Secondary: Brief Pain Inventory Short Form (BPI-SF) scores

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    End point title
    		 Brief Pain Inventory Short Form (BPI-SF) scores
    End point description
    The BPI-SF was a questionnaire used to assess pain intensity and interference with daily activities. The Pain Severity Subscale included four questions asking individuals to rate their pain intensity on a scale from 0 to 10, with higher scores indicating more severe pain. The Pain Interference Subscale consisted of seven items that assessed how pain had interfered with activities, rated on the same scale. Both subscales had a total score range of 0 to 10, with higher scores indicating more significant pain or interference.
    End point type
    Secondary
    End point timeframe
    Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Score on a scale
    median (full range (min-max))
        Pain severity- Baseline (n=2)
    1.63 (1.25 to 2.00)
        Pain severity- Cycle 4 Day 1 (n=1)
    0 (-9999 to 9999)
        Pain severity- Cycle 7 Day 1 (n=1)
    0.75 (-9999 to 9999)
        Pain severity- End of treatment (n=2)
    1.13 (0.00 to 2.25)
        Pain interference- Baseline (n=2)
    0.79 (0.00 to 1.57)
        Pain interference- Cycle 4 Day 1 (n=1)
    0 (-9999 to 9999)
        Pain interference- Cycle 7 Day 1 (n=1)
    0 (-9999 to 9999)
        Pain interference- End of treatment (n=2)
    1.07 (0 to 2.14)
    No statistical analyses for this end point

    Secondary: Number of participants with progression-free survival (PFS) according to RECIST 1.1

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    End point title
    		 Number of participants with progression-free survival (PFS) according to RECIST 1.1
    End point description
    The number of participants with PFS was defined as the count of participants who did not experience disease progression or death due to any cause during the study. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 based on local radiology review
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Alpelisib + fulvestrant
    Number of subjects analysed
    2
    Units: Participants
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start up to end of study, assessed up to 6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Alpelisib + fulvestrant
    Reporting group description
    		 Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle.

    Serious adverse events
    		 Alpelisib + fulvestrant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Alpelisib + fulvestrant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Diarrhea
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    18
    Decreased appetite
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2021
    The protocol was amended to address the request for supplementary information as described in the Deficiency letter received from the Swedish Health Authority (Medical Products Agency) on 22 April 2021 before the study started. The amended version was in accordance with the responses indicated by Novartis on 29 April 2021.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results.
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