Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-Label, Single-Arm, Post-Authorization Pragmatic Clinical Trial on the Safety and Efficacy of Xyntha (Moroctocog-Alfa (AF CC), Recombinant FVIII) in Subjects With Hemophilia A in Usual Care Settings in China

    Summary
    EudraCT number
    		 2015-005040-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2017
    First version publication date
    04 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1831083
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the product medically important event (MIE) (FVIII inhibitor development during the study) of Xyntha in subjects with hemophilia A in usual care settings in China.
    Protection of trial subjects
    This study used an External Data Monitoring Committee (E-DMC). The E-DMC periodically reviewed data from the study to ensure patient safety according to the Charter. The recommendations made by the E DMC to continue or alter the conduct of the study were forwarded to Pfizer for final decision.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    0
    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)
    4
    Children (2-11 years)
    64
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 As there were 2 subjects who rolled over from the surgical prophylaxis group to the on-demand group should be counted once in total column, the total number of baseline subjects was 85.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 On-Demand Group
    Arm description
    		 Subjects were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the subject's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xyntha
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were treated with intravenous infusions of Xyntha 500 IU/vial at a dose and frequency prescribed by the subject’s treating physician in accordance with the China Xyntha Package Insert.

    Arm title
    		 Surgical Prophylaxis Group
    Arm description
    		 Subjects were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and subject conditions.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xyntha
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and subject conditions.

    Number of subjects in period 1
    		On-Demand Group Surgical Prophylaxis Group
    Started
    73
    14
    Completed
    70
    14
    Not completed
    3
    0
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    On-Demand Group
    Reporting group description
    		 Subjects were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the subject's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).

    Reporting group title
    Surgical Prophylaxis Group
    Reporting group description
    		 Subjects were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and subject conditions.

    Reporting group values
    		 On-Demand Group Surgical Prophylaxis Group Total
    Number of subjects
    		 73 14 85
    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)
    		 4 0 4
        Children (2-11 years)
    		 60 6 64
        Adolescents (12-17 years)
    		 7 0 7
        Adults (18-64 years)
    		 2 8 10
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.2 ( 4.8 ) 21 ( 15 ) -
    Gender, Male/Female
    Units: Subjects
        FEMALE
    		 1 0 1
        MALE
    		 72 14 84

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    On-Demand Group
    Reporting group description
    		 Subjects were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the subject's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).

    Reporting group title
    Surgical Prophylaxis Group
    Reporting group description
    		 Subjects were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and subject conditions.

    Primary: Percentage of Subjects With Factor VIII (FVIII) Inhibitors

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Factor VIII (FVIII) Inhibitors [1]
    End point description
    Percentage of subjects with the product medically important event (MIE) (FVIII inhibitor development during the study).
    End point type
    Primary
    End point timeframe
    From Day 1 up to 28 calendar days after End of Treatment (subjects had received treatment for 6 months or when subjects had achieved 50 exposure days [EDs] whichever occurred first).
    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 analysis was planned for this endpoint.
    End point values
    		 On-Demand Group Surgical Prophylaxis Group
    Number of subjects analysed
    73
    14
    Units: percentage of subjects
        number (confidence interval 95%)
    8.22 (3.08 to 17.04)
    7.14 (0.18 to 33.87)
    No statistical analyses for this end point

    Secondary: Number of Subjects with All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of Subjects with All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence without regard to causality in a subject who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if it started for the first time in a subject on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 28 calendar after End of Treatment (subjects had received treatment for 6 months or when subjects had achieved 50 EDs whichever occurred first).
    End point values
    		 On-Demand Group Surgical Prophylaxis Group
    Number of subjects analysed
    73
    14
    Units: subjects
        Subjects with AEs
    65
    10
        Subjects with SAEs
    7
    1
    No statistical analyses for this end point

    Secondary: Response Assessment of On-Demand Treatment of Bleeds

    		 Close Top of page
    End point title
    		 Response Assessment of On-Demand Treatment of Bleeds [2]
    End point description
    The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No Response: No improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsens.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to subjects had received treatment for 6 months or when subjects had achieved 50 EDs whichever occurred first.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 On-Demand Group
    Number of subjects analysed
    73
    Units: percentage of infusions
    number (not applicable)
        Excellent
    46.9
        Good
    40
        Moderate
    12.7
        No Response
    0.3
        Data Not Recorded
    0.1
    No statistical analyses for this end point

    Secondary: Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment

    		 Close Top of page
    End point title
    		 Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment [3]
    End point description
    The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time).
    End point type
    Secondary
    End point timeframe
    From Day 1 up to subjects had received treatment for 6 months or when subjects had achieved 50 EDs whichever occurred first.
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 On-Demand Group
    Number of subjects analysed
    73
    Units: infusions
        arithmetic mean (standard deviation)
    1.6 ( 0.94 )
    No statistical analyses for this end point

    Secondary: Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group

    		 Close Top of page
    End point title
    		 Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group [4]
    End point description
    The number of bleeds resolved with 1, 2, 3, 4, or >4 infusions was reported for each of the categories (1, 2, 3, 4, or >4 infusions needed to treat the bleed), in which the numerator was the number of bleeds falling into each category, and the denominator was the total number of new bleeds across all subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to subjects had received treatment for 6 months or when subjects had achieved 50 EDs whichever occurred first.
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 On-Demand Group
    Number of subjects analysed
    73
    Units: percentage of bleeds
    number (not applicable)
        1 Infusion
    63
        2 Infusions
    21.9
        3 Infusions
    8.6
        4 Infusions
    6
        >4 Infusions
    0.5
    No statistical analyses for this end point

    Secondary: Hemostatic Efficacy for Surgical Prophylaxis Treatment

    		 Close Top of page
    End point title
    		 Hemostatic Efficacy for Surgical Prophylaxis Treatment [5]
    End point description
    Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic subject. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic subject. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported.
    End point type
    Secondary
    End point timeframe
    From day of surgery to postoperative period
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Surgical Prophylaxis Group
    Number of subjects analysed
    14
    Units: percentage of observations
    number (not applicable)
        Day of Surgery: Excellent
    71.4
        Day of Surgery: Good
    28.6
        Day of Surgery: Moderate
    0
        Day of Surgery: None
    0
        Post-Operative: Excellent
    75.5
        Post-Operative: Good
    24.5
        Post-Operative: Moderate
    0
        Post-Operative: None
    0
    No statistical analyses for this end point

    Secondary: Actual Estimated Blood Loss for Surgical Prophylaxis Treatment

    		 Close Top of page
    End point title
    		 Actual Estimated Blood Loss for Surgical Prophylaxis Treatment [6]
    End point description
    Number of subjects with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic subject.
    End point type
    Secondary
    End point timeframe
    From day of surgery to postoperative period
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Surgical Prophylaxis Group
    Number of subjects analysed
    13
    Units: partcipants
        Abnormal
    0
        Normal
    13
        Absence
    0
    No statistical analyses for this end point

    Secondary: Number of Units Transfused and Transfusion Type for Surgical Prophylaxis Treatment

    		 Close Top of page
    End point title
    		 Number of Units Transfused and Transfusion Type for Surgical Prophylaxis Treatment [7]
    End point description
    The number of units and types of blood products transfused during the intraoperative and the postoperative period were recorded.
    End point type
    Secondary
    End point timeframe
    From day of surgery to postoperative period.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 Surgical Prophylaxis Group
    Number of subjects analysed
    14
    Units: blood products
        Plasma
    4
        Packed red blood cell
    2
    No statistical analyses for this end point

    Secondary: Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment

    		 Close Top of page
    End point title
    		 Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment
    End point description
    The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each subject. The average infusion dose for each subject was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU).
    End point type
    Secondary
    End point timeframe
    Day 1 up to 6 months or 50 EDs whichever occurred first for On-Demand Group and Day of surgery to postoperative period for Surgical Prophylaxis Group
    End point values
    		 On-Demand Group Surgical Prophylaxis Group
    Number of subjects analysed
    73
    14
    Units: International Unit (IU)
    arithmetic mean (standard deviation)
        Average Infusion Dose
    674.68 ( 357.613 )
    1245.07 ( 494.268 )
        Total FVIII Consumption per Subject
    25211 ( 22035.35 )
    39860.7 ( 27546.15 )
    No statistical analyses for this end point

    Secondary: Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting

    		 Close Top of page
    End point title
    		 Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting [8]
    End point description
    LETE occurred in the on demand setting if 2 successive “No Response” ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to subjects had received treatment for 6 months or subjects had achieved 50 EDs whichever occurred first.
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint.
    End point values
    		 On-Demand Group
    Number of subjects analysed
    73
    Units: percentage of bleeding episodes
        number (confidence interval 95%)
    0.06 (0 to 0.35)
    No statistical analyses for this end point

    Secondary: Number of Confirmed LETE in the Low Recovery Setting

    		 Close Top of page
    End point title
    		 Number of Confirmed LETE in the Low Recovery Setting
    End point description
    LETE could also be lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. The only confounding factors for low recovery were: known presence or subsequent identification of a FVIII inhibitor; known compromised Xyntha; faulty administration of Xyntha, including inadequate dosing.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to subjects had received treatment for approximately 6 months or when subjects had achieved approximately 50 EDs whichever occurred first.
    End point values
    		 On-Demand Group Surgical Prophylaxis Group
    Number of subjects analysed
    73
    14
    Units: LETE bleeds
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 up to 28 calendar days after End of Treatment (subjects had received treatment for 6 months or when subjects had achieved 50 EDs whichever occurred first).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    On-Demand Group
    Reporting group description
    		 Subjects were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the subject's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).

    Reporting group title
    Surgical Prophylaxis Group
    Reporting group description
    		 Subjects were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and subject conditions.

    Serious adverse events
    		 On-Demand Group Surgical Prophylaxis Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 73 (9.59%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Gingival injury
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Factor VIII inhibition
         subjects affected / exposed
    6 / 73 (8.22%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 On-Demand Group Surgical Prophylaxis Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 73 (84.93%)
    9 / 14 (64.29%)
    General disorders and administration site conditions
    Local swelling
         subjects affected / exposed
    4 / 73 (5.48%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Peripheral swelling
         subjects affected / exposed
    15 / 73 (20.55%)
    0 / 14 (0.00%)
         occurrences all number
    36
    0
    Pyrexia
         subjects affected / exposed
    15 / 73 (20.55%)
    2 / 14 (14.29%)
         occurrences all number
    22
    4
    Reproductive system and breast disorders
    Penile oedema
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    4
    Penile pain
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 73 (13.70%)
    0 / 14 (0.00%)
         occurrences all number
    13
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    6 / 73 (8.22%)
    0 / 14 (0.00%)
         occurrences all number
    10
    0
    Joint injury
         subjects affected / exposed
    5 / 73 (6.85%)
    0 / 14 (0.00%)
         occurrences all number
    8
    0
    Incision site pain
         subjects affected / exposed
    0 / 73 (0.00%)
    4 / 14 (28.57%)
         occurrences all number
    0
    5
    Incision site oedema
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    9 / 73 (12.33%)
    0 / 14 (0.00%)
         occurrences all number
    18
    0
    Ligament sprain
         subjects affected / exposed
    4 / 73 (5.48%)
    0 / 14 (0.00%)
         occurrences all number
    5
    0
    Procedural complication
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Ecchymosis
         subjects affected / exposed
    9 / 73 (12.33%)
    0 / 14 (0.00%)
         occurrences all number
    12
    0
    Swelling face
         subjects affected / exposed
    6 / 73 (8.22%)
    0 / 14 (0.00%)
         occurrences all number
    7
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    24 / 73 (32.88%)
    2 / 14 (14.29%)
         occurrences all number
    147
    3
    Arthropathy
         subjects affected / exposed
    4 / 73 (5.48%)
    0 / 14 (0.00%)
         occurrences all number
    7
    0
    Haemarthrosis
         subjects affected / exposed
    3 / 73 (4.11%)
    1 / 14 (7.14%)
         occurrences all number
    3
    1
    Joint range of motion decreased
         subjects affected / exposed
    4 / 73 (5.48%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Joint swelling
         subjects affected / exposed
    34 / 73 (46.58%)
    3 / 14 (21.43%)
         occurrences all number
    121
    4
    Pain in extremity
         subjects affected / exposed
    18 / 73 (24.66%)
    0 / 14 (0.00%)
         occurrences all number
    31
    0
    Muscle swelling
         subjects affected / exposed
    11 / 73 (15.07%)
    0 / 14 (0.00%)
         occurrences all number
    13
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 73 (24.66%)
    0 / 14 (0.00%)
         occurrences all number
    21
    0
    Tonsillitis
         subjects affected / exposed
    6 / 73 (8.22%)
    1 / 14 (7.14%)
         occurrences all number
    9
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 73 (9.59%)
    0 / 14 (0.00%)
         occurrences all number
    16
    0

    More information

    		 Close Top of page

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

    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.
    None reported
    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.

    European Medicines Agency © 1995-Wed Apr 24 13:39:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA