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    Clinical Trial Results:
    An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Bintrafusp alfa (M7824) Clinical Studies

    Summary
    EudraCT number
    		 2021-000179-36
    Trial protocol
    		 FR   BE   ES   IT   DE  
    Global end of trial date
    21 Mar 2025

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MS200647_0054
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05061823
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Center, Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany, +49 6151725200, service@emdgroup.com
    Scientific contact
    Communication Center, Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany, +49 6151725200, service@emdgroup.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
    21 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was designed to provide continuous access to treatment with bintrafusp alfa for eligible subjects from ongoing bintrafusp alfa parent studies (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data. Study Duration: All subjects in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study. The study also includes a 5 years survival follow-up after last dose of the study treatment. Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    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
    Russian Federation: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Türkiye: 1
    Country: Number of subjects enrolled
    China: 1
    Country: Number of subjects enrolled
    Ukraine: 2
    Country: Number of subjects enrolled
    Japan: 3
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 9
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    23
    EEA total number of subjects
    3
    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)
    16
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 23 subjects consented for the rollover study.

    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
    Yes

    Arm title
    		 Biliary Tract Cancer
    Arm description
    		 Subjects with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bintrafusp alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Subjects who are entering the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

    Arm title
    		 Non-small Cell Lung Cancer
    Arm description
    		 Subjects with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bintrafusp alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Subjects who are entering the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

    Arm title
    		 Cervical Cancer
    Arm description
    		 Subjects with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bintrafusp alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Subjects who are entering the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

    Arm title
    		 Other (Colorectal cancer, Glioblastoma, Melanoma)
    Arm description
    		 Subjects with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bintrafusp alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Subjects who are entering the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

    Number of subjects in period 1 [1]
    		Biliary Tract Cancer Non-small Cell Lung Cancer Cervical Cancer Other (Colorectal cancer, Glioblastoma, Melanoma)
    Started
    10
    5
    3
    4
    Completed
    4
    3
    2
    1
    Not completed
    6
    2
    1
    3
         Adverse event, serious fatal
    1
    2
    1
    2
         Stop By Sponsor
    2
    -
    -
    1
         End Of Study Due To Suspension Of Drug Supply
    2
    -
    -
    -
         sponsor-requested study withdrawal
    1
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There was one subject who was enrolled in the study but did not receive any study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Biliary Tract Cancer
    Reporting group description
    		 Subjects with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Non-small Cell Lung Cancer
    Reporting group description
    		 Subjects with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Cervical Cancer
    Reporting group description
    		 Subjects with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Other (Colorectal cancer, Glioblastoma, Melanoma)
    Reporting group description
    		 Subjects with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group values
    		 Biliary Tract Cancer Non-small Cell Lung Cancer Cervical Cancer Other (Colorectal cancer, Glioblastoma, Melanoma) Total
    Number of subjects
    		 10 5 3 4 22
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 6 3 3 3 15
        From 65-84 years
    		 4 2 0 1 7
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 59 ( 10.3 ) 63 ( 7.4 ) 48 ( 14.4 ) 52 ( 16.9 ) -
    Sex: Female, Male
    Units: subjects
        Female
    		 3 2 3 1 9
        Male
    		 7 3 0 3 13
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 9 5 3 3 20
        Missing
    		 0 0 0 0 0
        Not collected
    		 1 0 0 1 2
    Race
    Units: Subjects
        Asian
    		 10 1 2 1 14
        American Indian or Alaska Native
    		 0 0 0 0 0
        Black or African American
    		 0 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        White
    		 0 3 1 3 7
        Other
    		 0 0 0 0 0
        Missing
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Biliary Tract Cancer
    Reporting group description
    		 Subjects with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Non-small Cell Lung Cancer
    Reporting group description
    		 Subjects with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Cervical Cancer
    Reporting group description
    		 Subjects with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Other (Colorectal cancer, Glioblastoma, Melanoma)
    Reporting group description
    		 Subjects with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subject's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Primary: Number of Subjects with Treatment Emergent Adverse events (TEAEs) and Treatment Related AEs (TRAEs)

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    End point title
    		 Number of Subjects with Treatment Emergent Adverse events (TEAEs) and Treatment Related AEs (TRAEs) [1]
    End point description
    An AE is any untoward medical occurrence in a subject or clinical study subject, temporarily associated with the use of study intervention, whether considered related to the study intervention or not. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. TRAE was defined as any AE considered as related to study treatment. Safety analysis set included all participants who received at least one dose of study intervention in the Rollover study.
    End point type
    Primary
    End point timeframe
    Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical and comparison analysis were performed in single arm for this endpoint.
    End point values
    		 Biliary Tract Cancer Non-small Cell Lung Cancer Cervical Cancer Other (Colorectal cancer, Glioblastoma, Melanoma)
    Number of subjects analysed
    10
    5
    3
    4
    Units: subjects
        TEAEs
    10
    5
    3
    4
        TRAEs
    10
    5
    3
    4
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from study day 1 in parent study to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. Full Analysis Set (FAS) included all participants who received at least one dose of study intervention in the Rollover study.
    End point type
    Secondary
    End point timeframe
    Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days)
    End point values
    		 Biliary Tract Cancer Non-small Cell Lung Cancer Cervical Cancer Other (Colorectal cancer, Glioblastoma, Melanoma)
    Number of subjects analysed
    10 [2]
    5 [3]
    3 [4]
    4 [5]
    Units: months
        median (confidence interval 90%)
    99999 (99999 to 999999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [2] - 99999=No observation; median and CI not reached, low number of events
    [3] - 99999=No observation;median and CI not reached, low number of events
    [4] - 99999=No observation;median and CI not reached, low number of events
    [5] - 99999=No observation;median and CI not reached, low number of events
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study intervention in the Rollover study to the last administration of study intervention + 30 days (approximately 39 months and 21 days)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Biliary Tract Cancer
    Reporting group description
    		 Subjects with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Cervical Cancer
    Reporting group description
    		 Subjects with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Non-small Cell Lung Cancer
    Reporting group description
    		 Subjects with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Reporting group title
    Other (Colorectal cancer, Glioblastoma, Melanoma)
    Reporting group description
    		 Subjects with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the subjects parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Subjects who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal.

    Serious adverse events
    		 Biliary Tract Cancer Cervical Cancer Non-small Cell Lung Cancer Other (Colorectal cancer, Glioblastoma, Melanoma)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 3 (33.33%)
    4 / 5 (80.00%)
    2 / 4 (50.00%)
         number of deaths (all causes)
    1
    1
    2
    2
         number of deaths resulting from adverse events
    Investigations
    Blood creatinine increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Disease progression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Diaphragmatic hernia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Biliary Tract Cancer Cervical Cancer Non-small Cell Lung Cancer Other (Colorectal cancer, Glioblastoma, Melanoma)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 10 (80.00%)
    3 / 3 (100.00%)
    3 / 5 (60.00%)
    3 / 4 (75.00%)
    Vascular disorders
    Hypotension
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    General disorders and administration site conditions
    Asthenia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    14
    0
    Axillary pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Hernia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza like illness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Localised oedema
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    2
    Immune system disorders
    Seasonal allergy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    4
    1
    Dyspnoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pneumonitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Productive cough
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pulmonary embolism
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Bilirubin conjugated increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood bilirubin increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    3
    Blood creatinine increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Lymphocyte count decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Neutrophil count decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Platelet count decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Weight decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Weight increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Ankle fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Thermal burn
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysaesthesia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Headache
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    1
    Somnolence
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    1
    18
    0
    Ear and labyrinth disorders
    Ear swelling
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vertigo
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dental caries
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    1
    Dry mouth
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Melaena
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stomatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 3 (66.67%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blister
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Decubitus ulcer
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis acneiform
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    Dry skin
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Eczema
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Erythema
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 3 (0.00%)
    3 / 5 (60.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    0
    10
    1
    Rash
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    2
    0
    1
    Skin mass
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urticaria
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bursitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in extremity
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Infections and infestations
    Abscess
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Carbuncle
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    1
    COVID-19
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    0
    0
    3
    Cystitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Furuncle
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    1
    Nasopharyngitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    2
    Onychomycosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumonia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash pustular
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tinea infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    2
    Urinary tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    2
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hyperlipidaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Hypoalbuminaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    3
    0
    Hypomagnesaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0

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    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
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    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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