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    Clinical Trial Results:
    An open-label, multi-center everolimus roll-over protocol for patients who have completed a previous Novartis-sponsored everolimus study and are judged by the investigator to benefit from continued everolimus treatment

    Summary
    EudraCT number
    		 2012-004707-12
    Trial protocol
    		 CZ   NL   IT   ES  
    Global end of trial date
    28 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2021
    First version publication date
    02 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRAD001C2X01B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01789281
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, 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
    28 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aimed to better characterize the long-term safety of everolimus in subjects currently being treated in a Novartis-sponsored studies and who were receiving clinical benefit on the current study treatment as judged by the Investigator
    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
    14 May 2013
    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: 2
    Country: Number of subjects enrolled
    United States: 15
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 3
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    Russian Federation: 2
    Worldwide total number of subjects
    34
    EEA total number of subjects
    11
    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)
    26
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There was no screening period. Patients enrolled into trial directly from the parent protocol.

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Everolimus
    Arm description
    		 Participants who were receiving everolimus in a Novartis-sponsored study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    RAD001
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject’s best interest.

    Arm title
    		 Everolimus+Sandostatin LAR
    Arm description
    		 Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    RAD001
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject’s best interest.

    Investigational medicinal product name
    Sandostatin LAR Depot
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet, Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.

    Number of subjects in period 1
    		Everolimus Everolimus+Sandostatin LAR
    Started
    22
    12
    Completed
    0
    2
    Not completed
    22
    10
         Consent withdrawn by subject
    1
    -
         Disease progression
    15
    4
         Adverse event, non-fatal
    5
    5
         Administrative problems
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    		 Participants who were receiving everolimus in a Novartis-sponsored study

    Reporting group title
    Everolimus+Sandostatin LAR
    Reporting group description
    		 Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study

    Reporting group values
    		 Everolimus Everolimus+Sandostatin LAR Total
    Number of subjects
    		 22 12 34
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 17 9 26
        From 65-84 years
    		 5 3 8
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.6 ( 9.52 ) 57.9 ( 11.30 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 9 6 15
        Male
    		 13 6 19

    End points

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    End points reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    		 Participants who were receiving everolimus in a Novartis-sponsored study

    Reporting group title
    Everolimus+Sandostatin LAR
    Reporting group description
    		 Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study

    Primary: Percentage of participants with Adverse Events (AEs) and Serious Adverse events (SAEs)

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    End point title
    		 Percentage of participants with Adverse Events (AEs) and Serious Adverse events (SAEs) [1]
    End point description
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. All SAEs were captured in safety database from enrollment. Safety data collection was changed in the protocol amendment released in March 2016: AEs and SAEs were captured in the clinical database from protocol amendment release (18 March 2016). Hence, SAEs from both safety database and clinical database are summarized separately.
    End point type
    Primary
    End point timeframe
    SAEs collected in safety database from baseline to end of the treatment (EOT) plus 30 days, up to approximately 7 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years
    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 planned for this endpoint
    End point values
    		 Everolimus Everolimus+Sandostatin LAR
    Number of subjects analysed
    22
    12
    Units: Participants
        SAEs (Safety database)
    6
    9
        Treatment-related SAEs (Safety database)
    1
    4
        AEs (Clinical Database)
    7
    7
        Tretament-related AEs (Clinical Database)
    4
    4
        SAEs (Clinical Database)
    2
    4
        Treatment-related SAEs (Clinical Database)
    0
    2
    No statistical analyses for this end point

    Secondary: Percentage of patients with clinical benefit

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    End point title
    		 Percentage of patients with clinical benefit
    End point description
    Percentage of patients with clinical benefit as judged by the investigator. Confirmation of clinical benefit was collected in clinical database after protocol amendment (release date 18 Mach 2016). Clinical benefit assessment before protocol amendment was done retrospectively.
    End point type
    Secondary
    End point timeframe
    After 3 months from baseline, every 3 months, until end of treatment, assessed up to 7 years
    End point values
    		 Everolimus Everolimus+Sandostatin LAR
    Number of subjects analysed
    9
    7
    Units: Participants
        At 3 months
    9
    7
        At 6 months
    8
    7
        At 9 months
    8
    7
        At 12 months
    8
    7
        At 15 months
    8
    7
        At 18 months
    8
    7
        At 21 months
    8
    7
        At 24 months
    6
    7
        At 27 months
    5
    7
        At 30 months
    3
    7
        At 33 months
    2
    7
        At 36 months
    1
    7
        At 39 months
    1
    7
        At 42 months
    1
    6
        At 45 months
    1
    6
        At 48 months
    1
    6
        At 51 months
    1
    6
        At 54 months
    0
    6
        At 57 months
    0
    5
        At 60 months
    0
    5
        At 63 months
    0
    4
        At 66 months
    0
    4
        At 69 months
    0
    3
        At 72 months
    0
    3
        At 75 months
    0
    3
        At 78 months
    0
    2
        At 81 months
    0
    1
        At 84 months
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approx. 7 years. Non-serious AEs were collected in clinical database from protocol amendment (18 March 2016) to EOT plus 30 days, up to approx. 4.5 years
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0.
    Reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    		 Everolimus

    Reporting group title
    Everolimus + Sandostatin LAR
    Reporting group description
    		 Everolimus + Sandostatin LAR

    Reporting group title
    All subjects
    Reporting group description
    		 All subjects

    Serious adverse events
    		 Everolimus Everolimus + Sandostatin LAR All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 22 (27.27%)
    9 / 12 (75.00%)
    15 / 34 (44.12%)
         number of deaths (all causes)
    1
    2
    3
         number of deaths resulting from adverse events
    0
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Renal cell carcinoma
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    Blood and lymphatic system disorders
    Aplastic anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Thrombocytopenia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Nephropathy
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 22 (9.09%)
    3 / 12 (25.00%)
    5 / 34 (14.71%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    Pyelonephritis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid intake reduced
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Everolimus Everolimus + Sandostatin LAR All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 22 (13.64%)
    5 / 12 (41.67%)
    8 / 34 (23.53%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    4
    4
    Pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    2
    Epistaxis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Pneumonitis
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 12 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    2
    0
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Investigations
    Blood chromogranin A increased
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Skin abrasion
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    4
    4
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    2
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 12 (25.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    7
    7
    Abdominal pain upper
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Duodenal stenosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Intestinal obstruction
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    2
    Large intestinal obstruction
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    2
    Stomatitis
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences all number
    1
    2
    3
    Vomiting
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    3
    3
    Skin and subcutaneous tissue disorders
    Onychoclasis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Dry skin
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Psoriasis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    3
    Costochondritis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    2
    Spinal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    5
    5
    Pneumonia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences all number
    1
    4
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 12 (16.67%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2016
    The main purpose of the amendment was to change the primary endpoint to safety to better characterize the long-term safety of the compound. In addition, the protocol was amended to include the collection of all AEs (including non-serious AEs) and an investigator attestation of continued clinical benefit.

    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.
    The protocol was designed to collect SAEs and protocol defined AESIs in the Safety database. The protocol was amended in 2016 (3 years after study was initiated) to include all AEs (non-SAEs, SAEs, and AESIs) to be collected in the clinical database.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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