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   43870   clinical trials with a EudraCT protocol, of which   7289   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:
    A Randomised, Multi-Centre, Assessor-Blinded, Active-Controlled, Parallel Group, Equivalence Phase III Study Comparing the Safety and Efficacy of USV Pegfilgrastim and Neulasta® in Breast Cancer Patients Undergoing Myelosuppressive Chemotherapy

    Summary
    EudraCT number
    		 2015-000266-64
    Trial protocol
    		 HU   BG  
    Global end of trial date
    21 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2018
    First version publication date
    08 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PEGF/USV/P3/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    USV PRIVATE LIMITED
    Sponsor organisation address
    ARVIND VITHAL GANDHI CHOWK, BSD MARG, GOVANDI, MUMBAI, India, 400088
    Public contact
    Dr. Esmail Samiwala, USV Private Limited, Arvind Vithal Gandhi Chowk, BSD Marg, Govandi, Mumbai 400088, India, +91 22 25561197, esmail.samiwala@usv.in
    Scientific contact
    Dr. Vasant Joshi, USV Private Limited, Arvind Vithal Gandhi Chowk, BSD Marg, Govandi, Mumbai 400088, India, +91 22 25561129, vasant.joshi@usv.in
    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
    21 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of USV Pegfilgrastim compared to Neulasta® with respect to the mean duration of severe neutropenia (DSN) defined as the mean number of days with Grade 4 neutropenia [absolute neutrophil count (ANC) less than 0.5 × 109/L], during Cycle 1 of the chemotherapy treatment.
    Protection of trial subjects
    Before initiating this clinical study, the investigator/institution obtained the written and dated approval/favourable opinion from the appropriately constituted Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the Clinical Study Protocol, Investigational Drug Brochure, written Informed Consent Form, and any other written information provided to subjects. The study was carried out in compliance with the Clinical Study Protocol and the principles of Good Clinical Practice (GCP), as per standard operating procedures (SOP) and in accordance with the International Council for Harmonisation (ICH) ICH E6 GCP, the EU Clinical Trials Directive 2001/20/EC, the principles of the accepted version of the World Medical Association Declaration of Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 312, Subpart D, of Title 21 of the Code of Federal Regulations (CFR) and as per all applicable local regulatory guidelines.
    Background therapy
    		 All eligible subjects received a maximum of 6 cycles of TAC chemotherapy (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2) during the treatment period.
    Evidence for comparator
    		 Selected reference product (comparator) for this study was EU-licensed Neulasta®. Neulasta® is a colourless solution intended for s.c. injection commercially available as prefilled syringes.
    Actual start date of recruitment
    21 Oct 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
    Romania: 15
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Georgia: 133
    Country: Number of subjects enrolled
    Serbia: 23
    Country: Number of subjects enrolled
    Ukraine: 46
    Country: Number of subjects enrolled
    Russian Federation: 20
    Worldwide total number of subjects
    248
    EEA total number of subjects
    26
    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)
    216
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Total 254 subjects were enrolled (172 in USV Pegfilgrastim and 82 in Neulasta arm). Subjects were randomised in a ratio of 2:1 to receive either USV Pegfilgrastim or EU-licensed Neulasta® (active control treatment) in a country stratified manner. A total of 6 subjects, discontinued the study before receipt of first dose of IMP.

    Pre-assignment
    Screening details
    		 A total of 296 subjects from 31 centres were screened for inclusion into the study of which 42 subjects were classified as screen failures. Forty-two subjects (16.5%) were considered as screen failures.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was assessor blinded trial. The allocated treatment was disclosed only to the unblinded study staff. There were separate blinded and unblinded study teams in each study site. The unblinded team member(s) were responsible for the receipt, accountability, preparation, and administration of the study treatment (pegfilgrastim treatment). The assessor(s) –the prinprincipal investigator and other co-investigators participating in the subject assessments were blinded to the treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 USV PEGFILGRASTIM
    Arm description
    		 The subjects who met eligibility criteria were randomized to one of the two arms. Subjects randomized to USV Pegfilgrastim were to receive USV Pegfilgrastim in all 6 chemotherapy cycles. Out of 248 subjects who received at least one dose of Pegfilgrastim, 166 were in USVPegfilgrastim group, 152 completed treatment period and 147 completed follow up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    USV Pegfilgrastim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    USV Pegfilgrastim is a clear colourless sterile solution supplied in a single-dose pre-filled sterile syringe, each containing 6 mg (based on protein content) of pegfilgrastim in 0.6 mL solution for subcutaneous injection. The treatment with USV Pegfilgrastim was administered by the unblinded team member on Day 2 of each chemotherapy cycle (at least 24 hour after administration of chemotherapy) and consisted of a single 6 mg subcutaneous (s.c.) injection per cycle.

    Arm title
    		 Neulasta
    Arm description
    		 82 subjects were randomized and received at least one dose of EU-licensed Neulasta®. 78 subjects in this arm completed the treatment period and 77 subjects completed the follow up period. The treatment with Neulasta® (EU-licensed comparator) was administered by the unblinded team member on Day 2 (D2) of each chemotherapy cycle (at least 24h after administration of chemotherapy) and consisted of a single 6 mg subcutaneous (s.c.) injection per cycle.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EU-licensed Neulasta
    Investigational medicinal product code
    Other name
    Pegfilgrastim
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose 6mg/mL pre-filled syringe of EU-licensed Neulasta® was administered for each chemotherapy cycle, as a subcutaneous injection on day 2 of each chemotherapy cycle (at least 24h after chemotherapy).

    Number of subjects in period 1
    		USV PEGFILGRASTIM Neulasta
    Started
    166
    82
    Completed
    147
    77
    Not completed
    19
    5
         Physician decision
    1
    1
         Consent withdrawn by subject
    15
    4
         Adverse event, non-fatal
    3
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    USV PEGFILGRASTIM
    Reporting group description
    		 The subjects who met eligibility criteria were randomized to one of the two arms. Subjects randomized to USV Pegfilgrastim were to receive USV Pegfilgrastim in all 6 chemotherapy cycles. Out of 248 subjects who received at least one dose of Pegfilgrastim, 166 were in USVPegfilgrastim group, 152 completed treatment period and 147 completed follow up period.

    Reporting group title
    Neulasta
    Reporting group description
    		 82 subjects were randomized and received at least one dose of EU-licensed Neulasta®. 78 subjects in this arm completed the treatment period and 77 subjects completed the follow up period. The treatment with Neulasta® (EU-licensed comparator) was administered by the unblinded team member on Day 2 (D2) of each chemotherapy cycle (at least 24h after administration of chemotherapy) and consisted of a single 6 mg subcutaneous (s.c.) injection per cycle.

    Reporting group values
    		 USV PEGFILGRASTIM Neulasta Total
    Number of subjects
    		 166 82 248
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age in years
    Units: years
        arithmetic mean (standard deviation)
    		 52.4 ± 11.26 53.4 ± 11.02 -
    Gender categorical
    Units: Subjects
        Female
    		 166 82 248
        Male
    		 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    USV PEGFILGRASTIM
    Reporting group description
    		 The subjects who met eligibility criteria were randomized to one of the two arms. Subjects randomized to USV Pegfilgrastim were to receive USV Pegfilgrastim in all 6 chemotherapy cycles. Out of 248 subjects who received at least one dose of Pegfilgrastim, 166 were in USVPegfilgrastim group, 152 completed treatment period and 147 completed follow up period.

    Reporting group title
    Neulasta
    Reporting group description
    		 82 subjects were randomized and received at least one dose of EU-licensed Neulasta®. 78 subjects in this arm completed the treatment period and 77 subjects completed the follow up period. The treatment with Neulasta® (EU-licensed comparator) was administered by the unblinded team member on Day 2 (D2) of each chemotherapy cycle (at least 24h after administration of chemotherapy) and consisted of a single 6 mg subcutaneous (s.c.) injection per cycle.

    Primary: Mean duration of severe neutropenia (Grade 4), defined as the number of days in which the subject had an ANC < 0.5 × 10^9/L during Cycle 1 of chemotherapy.

    		 Close Top of page
    End point title
    		 Mean duration of severe neutropenia (Grade 4), defined as the number of days in which the subject had an ANC < 0.5 × 10^9/L during Cycle 1 of chemotherapy.
    End point description
    The main efficacy endpoint was defined as the mean number of days of Grade 4 neutropenia (ANC below 0.5 x 10^9/L) during the first treatment cycle. The primary analysis of the duration of severe neutropenia in Cycle 1 consisted in testing equivalence of USV Pegfilgrastim and Neulasta®. The Least-square means (LSMeans) were estimated within a general linear model framework (using proc genmod in SAS), accounting for treatment arm, and applying a log link. LS Mean difference and 95% Confidence Interval (CI) between the two treatment arms was then back-transformed by exponentiation, resulting in a ratio of means and its 95% CI. Equivalence was concluded if the 95% CI of the ratio of means was entirely contained in the interval [0.65, 1.55].
    End point type
    Primary
    End point timeframe
    First Chemotherapy cycle
    End point values
    		 USV PEGFILGRASTIM Neulasta
    Number of subjects analysed
    166
    82
    Units: LSM
        least squares mean (standard deviation)
    1.58 ± 1.207
    1.65 ± 1.231
    Statistical analysis title
    		 Statistical Analysis of Primary endpoint
    Statistical analysis description
    The DSN in Cycle 1 was the primary endpoint for the comparative assessment of efficacy of USV Pegfilgrastim to Neulasta®. Severe neutropenia was defined as occurrence of ANC below 0.5 x 109/L. Equivalence was concluded if the 95% CI of the ratio of least-square means of DSN for the two treatment arms was entirely contained in the interval [0.65-1.55].
    Comparison groups
    USV PEGFILGRASTIM v Neulasta
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 LSM Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.18
    Notes
    [1] - Equivalence was concluded if the 95% CI of the ratio of least-square means of DSN for the two treatment arms was entirely contained in the interval [0.65-1.55].

    Secondary: Mean duration of severe neutropenia (DSN) during Cycles 2

    		 Close Top of page
    End point title
    		 Mean duration of severe neutropenia (DSN) during Cycles 2
    End point description
    Duration of Severe Neutropenia (Days) in Cycle 2-6 was analyzed. For each cycle, least square Means (95% Cl) of Treatment Arms and their Ratio, Estimated within a Generalized Linear Model Accounting for the Treatment Effect (FAS)
    End point type
    Secondary
    End point timeframe
    Cycle 2
    End point values
    		 USV PEGFILGRASTIM Neulasta
    Number of subjects analysed
    166
    82
    Units: LSM of Duration of severe Neutropenia
        least squares mean (confidence interval 95%)
    0.96 (0.79 to 1.17)
    0.99 (0.76 to 1.29)
    No statistical analyses for this end point

    Secondary: Mean Duration of severe nuetropenia Cycle 4

    		 Close Top of page
    End point title
    		 Mean Duration of severe nuetropenia Cycle 4
    End point description
    Duration of Severe Neutropenia (Days) in Cycle 4: Least-Square Means (95% Cl) of Treatment Arms and their Ratio, Estimated within a Generalized Linear Model Accounting for the Treatment Effect (FAS)
    End point type
    Secondary
    End point timeframe
    Cycle 4
    End point values
    		 USV PEGFILGRASTIM Neulasta
    Number of subjects analysed
    166
    82
    Units: Least Square Mean
        least squares mean (confidence interval 95%)
    1.03 (0.84 to 1.26)
    0.98 (0.73 to 1.30)
    No statistical analyses for this end point

    Secondary: Mean Duration of severe neutropenia Cycle 3

    		 Close Top of page
    End point title
    		 Mean Duration of severe neutropenia Cycle 3
    End point description
    Duration of Severe Neutropenia (Days) in Cycle 3: Least-Square Means (95% Cl) of Treatment Arms and their Ratio, Estimated within a Generalized Linear Model Accounting for the Treatment Effect (FAS)
    End point type
    Secondary
    End point timeframe
    Cycle 4
    End point values
    		 USV PEGFILGRASTIM Neulasta
    Number of subjects analysed
    166
    82
    Units: Least Square Mean
        least squares mean (confidence interval 95%)
    0.89 (0.73 to 1.07)
    1.01 (0.79 to 1.3)
    No statistical analyses for this end point

    Secondary: Mean duration of severe neutropenia Cycle 5

    		 Close Top of page
    End point title
    		 Mean duration of severe neutropenia Cycle 5
    End point description
    Duration of Severe Neutropenia (Days) in Cycle 5: Least-Square Means (95% Cl) of Treatment Arms and their Ratio, Estimated within a Generalized Linear Model Accounting for the Treatment Effect (FAS)
    End point type
    Secondary
    End point timeframe
    Cycle 5
    End point values
    		 USV PEGFILGRASTIM Neulasta
    Number of subjects analysed
    166
    82
    Units: Least square Mean
        least squares mean (confidence interval 95%)
    0.92 (0.75 to 1.12)
    1.0 (0.76 to 1.32)
    No statistical analyses for this end point

    Secondary: Mean duration of severe neutropenia cycle 6

    		 Close Top of page
    End point title
    		 Mean duration of severe neutropenia cycle 6
    End point description
    Duration of Severe Neutropenia (Days) in Cycle 6: Least-Square Means (95% Cl) of Treatment Arms and their Ratio, Estimated within a Generalized Linear Model Accounting for the Treatment Effect (FAS)
    End point type
    Secondary
    End point timeframe
    Cycle 6
    End point values
    		 USV PEGFILGRASTIM Neulasta
    Number of subjects analysed
    166
    82
    Units: Least Square Mean
        least squares mean (confidence interval 95%)
    1.12 (0.9 to 1.38)
    1.09 (0.81 to 1.47)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were assessed from randomization to end of study period
    Adverse event reporting additional description
    Adverse events were reported by the subjects
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    USV PEGFILGRASTIM
    Reporting group description
    		 The subjects who met eligibility criteria were randomized to one of the two arms. Subjects randomized to USV Pegfilgrastim were to receive USV Pegfilgrastim in all 6 chemotherapy cycles. Out of 248 subjects who received at least one dose of Pegfilgrastim, 166 were in USVPegfilgrastim group, 152 completed treatment period and 147 completed follow up period.

    Reporting group title
    Neulasta
    Reporting group description
    		 82 subjects were randomized and received at least one dose of EU-licensed Neulasta®. 78 subjects in this arm completed the treatment period and 77 subjects completed the follow up period. The treatment with Neulasta® (EU-licensed comparator) was administered by the unblinded team member on Day 2 (D2) of each chemotherapy cycle (at least 24h after administration of chemotherapy) and consisted of a single 6 mg subcutaneous (s.c.) injection per cycle.

    Serious adverse events
    		 USV PEGFILGRASTIM Neulasta
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 166 (5.42%)
    3 / 82 (3.66%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastasis to central nervous system
    Additional description: Serious Adverse Event during Follow up period
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral T-cell lymphoma unspecified
    Additional description: SAE during follow up period
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (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
    Agranulocytosis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    6 / 166 (3.61%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Breast abscess
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 USV PEGFILGRASTIM Neulasta
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    164 / 166 (98.80%)
    82 / 82 (100.00%)
    Nervous system disorders
    Dizziness
    Additional description: AE during treatment period
         subjects affected / exposed
    36 / 166 (21.69%)
    15 / 82 (18.29%)
         occurrences all number
    54
    46
    Headache
    Additional description: AE during treatment period
         subjects affected / exposed
    46 / 166 (27.71%)
    18 / 82 (21.95%)
         occurrences all number
    80
    25
    Blood and lymphatic system disorders
    Anaemia
    Additional description: AEs in Treatment Period)
         subjects affected / exposed
    15 / 166 (9.04%)
    9 / 82 (10.98%)
         occurrences all number
    47
    30
    Febrile neutropenia
    Additional description: AEs during treatment period
         subjects affected / exposed
    9 / 166 (5.42%)
    2 / 82 (2.44%)
         occurrences all number
    9
    2
    Leukocytosis
    Additional description: AE during treatment period
         subjects affected / exposed
    6 / 166 (3.61%)
    5 / 82 (6.10%)
         occurrences all number
    34
    28
    leukopenia
    Additional description: AE during treatment period
         subjects affected / exposed
    74 / 166 (44.58%)
    36 / 82 (43.90%)
         occurrences all number
    364
    184
    Neutropenia
    Additional description: AE during treatment period
         subjects affected / exposed
    130 / 166 (78.31%)
    63 / 82 (76.83%)
         occurrences all number
    788
    427
    Thrombocytopenia
    Additional description: AE during treatment period
         subjects affected / exposed
    25 / 166 (15.06%)
    8 / 82 (9.76%)
         occurrences all number
    93
    31
    General disorders and administration site conditions
    Asthenia
    Additional description: AE during treatment period
         subjects affected / exposed
    35 / 166 (21.08%)
    18 / 82 (21.95%)
         occurrences all number
    65
    30
    Fatigue
    Additional description: AE during treatment period
         subjects affected / exposed
    21 / 166 (12.65%)
    12 / 82 (14.63%)
         occurrences all number
    31
    32
    Injection site reaction
    Additional description: AE during treatment period
         subjects affected / exposed
    16 / 166 (9.64%)
    8 / 82 (9.76%)
         occurrences all number
    72
    32
    Gastrointestinal disorders
    Abdominal pain
    Additional description: AE during treatment period
         subjects affected / exposed
    9 / 166 (5.42%)
    2 / 82 (2.44%)
         occurrences all number
    11
    2
    Abdominal pain upper
    Additional description: AE during treatment period
         subjects affected / exposed
    12 / 166 (7.23%)
    9 / 82 (10.98%)
         occurrences all number
    12
    14
    Diarrhoea
    Additional description: AE during treatment period
         subjects affected / exposed
    33 / 166 (19.88%)
    20 / 82 (24.39%)
         occurrences all number
    38
    24
    Nausea
    Additional description: AE during treatment period
         subjects affected / exposed
    79 / 166 (47.59%)
    38 / 82 (46.34%)
         occurrences all number
    206
    158
    Vomiting
    Additional description: AE during treatment period
         subjects affected / exposed
    17 / 166 (10.24%)
    7 / 82 (8.54%)
         occurrences all number
    21
    11
    Skin and subcutaneous tissue disorders
    Alopecia
    Additional description: AE during treatment period
         subjects affected / exposed
    62 / 166 (37.35%)
    30 / 82 (36.59%)
         occurrences all number
    69
    32
    Musculoskeletal and connective tissue disorders
    Bone pain
    Additional description: AE during treatment period
         subjects affected / exposed
    54 / 166 (32.53%)
    27 / 82 (32.93%)
         occurrences all number
    473
    165
    Spinal pain
    Additional description: AE during treatment period
         subjects affected / exposed
    13 / 166 (7.83%)
    8 / 82 (9.76%)
         occurrences all number
    24
    40

    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-Tue Apr 30 14:01:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA