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    Clinical Trial Results:
    FIRST LINE THERAPY OF ADVANCED STAGE FOLLICULAR LYMPHOMA IN PATIENTS < 60 YEARS NOT ELIGIBLE FOR STANDARD IMMUNOCHEMOTHERAPY AND ALL PATIENTS ≥ 60 YEARS Prospective randomized evaluation of single agent GA101 versus GA101 plus Bendamustine followed by GA101

    Summary
    EudraCT number
    		 2016-000755-27
    Trial protocol
    		 DE  
    Global end of trial date
    31 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2026
    First version publication date
    29 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GABe2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03492775
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Klinikum der Universität München
    Sponsor organisation address
    Marchioninistr 15, München, Germany, 81377
    Public contact
    Studienzentrale für Hämatologie, LMU Klinikum, Medizinische Klinik III, Studienzentrale für Hämatologie, 0049 89440074900, studyce@med.uni-muenchen.de
    Scientific contact
    Dr. Christian Schmidt, LMU Klinikum, Medizinische Klinik III, Studienzentrale für Hämatologie, 0049 089440077907, studyce@med.uni-muenchen.de
    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
    07 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, ‘compromised’ patients and in all older patients (≥ 60 years) i. For the assessment of the anti-lymphoma activity the “overall response rate (ORR)” is applied as primary endpoint. Overall response is defined as complete or partial response after 19 – 21 weeks
    Protection of trial subjects
    To ensure patients' safety, a Data Safety Monitoring Committee of independent members with pertinent expertise has been established. This international group should review on regular basis safety relevant data and provide an assessment on the patient’s overall safety. The sponsor/sponsor delegated person is under obligation to monitor the progress of the clinical trial with regard to safety-relevant developments and, if necessary, initiate the premature termination of a treatment arm or the entire clinical trial. A treatment arm or the entire clinical trial must be terminated prematurely if: − New toxicological or pharmacological SAEs invalidate the earlier benefit-to-risk ratio for the subject. − Adverse events occurring in such severity and frequency that the proposed schedule can no longer be adhered to. − The sponsor/coordinating investigator (German LKP) considers that the termination of the trial is necessary. − Indications arise that the subjects' safety is no longer guaranteed. − The event-free survival (EFS) is unexpectedly inferior in one of the treatment arms − An insufficient recruitment rate makes a successful conclusion of the clinical trial appear impossible. − The reasons for such a decision should be documented in written form − This decision requires the consultation of the DSMC.
    Background therapy
    		 No Background treatment
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2017
    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
    Germany: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    4
    From 65 to 84 years
    40
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Start of recruitment 13-DEC-2017, end of recruitment 27-NOV-2020

    Pre-assignment
    Screening details
    		 Screening was done according to inclusion/exclusion criteria of the trial protocol. There where 3 screening failures reported during the recrutiment period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Obinutuzumab single agent. Patients received obinutuzumab as a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Patients with at least a stable disease received obinutuzumab as a flat dose of 1000 mg at weeks 21, 29, 37 and 45.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    Other name
    GAZYVARO
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Obinutuzumab was administered intravenously at a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Patients with at least a stable disease additionally received obinutuzumab at a flat dose of 1000 mg on day 1 of weeks 21, 29, 37 and 45.

    Arm title
    		 Arm B
    Arm description
    		 Obinutuzumab plus Bendamustine. Patients received obinutuzumab as a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Additionally, they received bendamustine at a dose of 70 mg/m2 by intravenous infusion on days 1 and 2 of each of four 28-day cycles. Patients with at least a stable disease received obinutuzumab as a flat dose of 1000 mg at weeks 21, 29, 37 and 45.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    Other name
    GAZYVARO
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Obinutuzumab was administered intravenously at a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Patients with at least a stable disease additionally received obinutuzumab at a flat dose of 1000 mg on day 1 of weeks 21, 29, 37 and 45.

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Levact, Ribomustine
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Bendamustine was administered at a dose of 70 mg/m2 by intravenous infusion on days 1 and 2 of each of four 28-day cycles.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    23
    23
    Completed
    23
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Obinutuzumab single agent. Patients received obinutuzumab as a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Patients with at least a stable disease received obinutuzumab as a flat dose of 1000 mg at weeks 21, 29, 37 and 45.

    Reporting group title
    Arm B
    Reporting group description
    		 Obinutuzumab plus Bendamustine. Patients received obinutuzumab as a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Additionally, they received bendamustine at a dose of 70 mg/m2 by intravenous infusion on days 1 and 2 of each of four 28-day cycles. Patients with at least a stable disease received obinutuzumab as a flat dose of 1000 mg at weeks 21, 29, 37 and 45.

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 23 23 46
    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)
    		 1 3 4
        From 65-84 years
    		 20 20 40
        85 years and over
    		 2 0 2
    Age continuous
    Units: years
        median (full range (min-max))
    		 76 (47 to 89) 74 (62 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 11 13 24
        Male
    		 12 10 22
    Histology
    Units: Subjects
        FL grade 1
    		 8 4 12
        FL grade 2
    		 12 13 25
        FL grade 3a
    		 3 6 9
    Ann Arbor stage
    Units: Subjects
        I-II
    		 5 2 7
        III-IV
    		 18 21 39
    LDH
    Lactate dehydrogenase
    Units: Subjects
        <=upper normal
    		 16 19 35
        >upper normal
    		 7 4 11
    Hb
    Hemoglobin
    Units: Subjects
        <12g/dL
    		 7 8 15
        >=12g/dL
    		 16 15 31
    Involved nodal areas
    Units: Subjects
        <=4
    		 15 12 27
        >4
    		 8 11 19
    FLIPI
    Number of FLIPI risk factors
    Units: Subjects
        FLIPI=0
    		 1 0 1
        FLIPI=1
    		 1 2 3
        FLIPI=2
    		 9 7 16
        FLIPI=3
    		 5 7 12
        FLIPI=4
    		 7 5 12
        FLIPI=5
    		 0 2 2
    ECOG
    Eastern Cooperative Oncology Group Performance Status
    Units: Subjects
        ECOG=0
    		 10 12 22
        ECOG=1
    		 9 8 17
        ECOG=2
    		 3 2 5
        ECOG=3
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Obinutuzumab single agent. Patients received obinutuzumab as a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Patients with at least a stable disease received obinutuzumab as a flat dose of 1000 mg at weeks 21, 29, 37 and 45.

    Reporting group title
    Arm B
    Reporting group description
    		 Obinutuzumab plus Bendamustine. Patients received obinutuzumab as a flat dose of 1000 mg on day 1 of each of four 28-day cycles and on days 8 and 15 of cycle 1. Additionally, they received bendamustine at a dose of 70 mg/m2 by intravenous infusion on days 1 and 2 of each of four 28-day cycles. Patients with at least a stable disease received obinutuzumab as a flat dose of 1000 mg at weeks 21, 29, 37 and 45.

    Primary: Overall response rate (ORR)

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    End point title
    		 Overall response rate (ORR)
    End point description
    Overall response is defined as complete or partial response at the end of the initial treatment phase (after 19-21 weeks).
    End point type
    Primary
    End point timeframe
    End of the initial treatment phase (after 19-21 weeks)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    23
    23
    Units: subjects
        overall response = yes
    17
    22
        overall response = no
    6
    1
    Statistical analysis title
    		 Evaluation of primary outcome in arm A
    Statistical analysis description
    A one-sided binomiat test was used to test if the overall response rate in arm A was significantly higher than the pre-specified value of 61%. No statistical comparison between treatment arms A and B was performed. The binomial test was conducted within each treatment arm separately.
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 one-sided binomial test
    Parameter type
    		 rate
    Point estimate
    0.739
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.55
         upper limit
    		 -
    Statistical analysis title
    		 Evaluation of primary outcome in arm B
    Statistical analysis description
    A one-sided binomiat test was used to test if the overall response rate in arm B was significantly higher than the pre-specified value of 61%. No statistical comparison between treatment arms A and B was performed. The binomial test was conducted within each treatment arm separately.
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00018
    Method
    		 one-sided binomial test
    Parameter type
    		 rate
    Point estimate
    0.957
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.81
         upper limit
    		 -

    Secondary: 1-year progression-free survival

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    End point title
    		 1-year progression-free survival
    End point description
    1-year progression-free survival as estimated by the Kaplan-Meier method
    End point type
    Secondary
    End point timeframe
    From registration to one year after registration
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    23
    23
    Units: subjects
        number (confidence interval 95%)
    69.6 (53.1 to 91.2)
    87.0 (74.2 to 100)
    No statistical analyses for this end point

    Secondary: 2-year progression-free survival

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    End point title
    		 2-year progression-free survival
    End point description
    Two-year progression-free survival as estimated by the Kaplan-Meier method
    End point type
    Secondary
    End point timeframe
    From registration to two years after registration.
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    23
    23
    Units: subjects
        number (confidence interval 95%)
    65.2 (48.4 to 87.9)
    78.0 (62.7 to 97.1)
    No statistical analyses for this end point

    Secondary: 1-year overall survival

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    End point title
    		 1-year overall survival
    End point description
    One-year overall survival as estimated by the Kaplan-Meier method
    End point type
    Secondary
    End point timeframe
    From registration to one year after registration
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    23
    23
    Units: subjects
        number (confidence interval 95%)
    100 (85.2 to 100)
    91.3 (80.5 to 100)
    No statistical analyses for this end point

    Secondary: 2-year overall survival

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    End point title
    		 2-year overall survival
    End point description
    Two-year overall survival as estimated by the Kaplan-Meier method
    End point type
    Secondary
    End point timeframe
    From registration to two years after registration
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    23
    23
    Units: subjects
        number (confidence interval 95%)
    86.5 (73.4 to 100)
    87.0 (74.2 to 100)
    No statistical analyses for this end point

    Secondary: 1-year time to treatment failure

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    End point title
    		 1-year time to treatment failure
    End point description
    1-year time to treatment failure as estimated by the Kaplan-Meier method
    End point type
    Secondary
    End point timeframe
    From registration to one year after registration
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    23
    23
    Units: subjects
        number (confidence interval 95%)
    65.2 (48.4 to 87.9)
    87.0 (74.2 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From registration to end of study
    Adverse event reporting additional description
    There were 166 adverse events in total, 77 of grade 1, 58 of grade 2, 22 of grade 3, 7 of grade 4 and 2 of grade 5.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 All patients that started treatment in arm A

    Reporting group title
    Arm B
    Reporting group description
    		 All patients who started treatment in arm B.

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 23 (39.13%)
    9 / 23 (39.13%)
         number of deaths (all causes)
    4
    4
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoma of skin
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Local swelling
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    upper respiratory infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 23 (73.91%)
    21 / 23 (91.30%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 23 (8.70%)
         occurrences all number
    2
    4
    Neutropenia
         subjects affected / exposed
    1 / 23 (4.35%)
    4 / 23 (17.39%)
         occurrences all number
    2
    7
    Thrombocytopenia
         subjects affected / exposed
    4 / 23 (17.39%)
    2 / 23 (8.70%)
         occurrences all number
    5
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Oedema limbs
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    4 / 23 (17.39%)
    2 / 23 (8.70%)
         occurrences all number
    4
    2
    Fever
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 23 (13.04%)
         occurrences all number
    1
    4
    Diarrhoea
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Flatulence
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    2 / 23 (8.70%)
    5 / 23 (21.74%)
         occurrences all number
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 23 (13.04%)
         occurrences all number
    2
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Lung infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 23 (13.04%)
         occurrences all number
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Hyperuricaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Aug 2017
    New RSI Gazyvaro and Levact Editorial changes
    16 Oct 2018
    Changes in regard to new RSI Gazyvaro and Levact.
    12 Aug 2019
    Changed study design from Phase III to Phase II. Change in inclusion criteria (open for patient aged 60 and above) Implementation of new interim analysis for IRB.
    11 Dec 2020
    Changes in regard to new RSI. Changes in the recruitment period.
    03 Nov 2021
    Changed follow up period

    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
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