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    Clinical Trial Results:
    A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)

    Summary
    EudraCT number
    		 2018-000714-37
    Trial protocol
    		 GB   ES   FR   PL  
    Global end of trial date
    19 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2025
    First version publication date
    22 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3475-799
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03631784
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.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
    19 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and estimation of objective response rate (ORR) by blinded independent central review (BICR).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2018
    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
    Australia: 15
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 23
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    Poland: 21
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    216
    EEA total number of subjects
    100
    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)
    104
    From 65 to 84 years
    109
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC), who had received no prior anticancer therapy for their disease were recruited into two cohorts.

    Pre-assignment
    Screening details
    		 Of 216 participants enrolled/allocated in the trial, 214 received treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin
    Arm description
    		 Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-3475
    Investigational medicinal product code
    Other name
    Pembrolizumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC6 IV infusion on Day 1 of the 21-day cycle for Cycle 1

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 45 mg/m^2 IV infusion on Days 1, 8, 15 of each 3-week cycle for Cycles 2, and 3 during radiation therapy

    Arm title
    		 Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Arm description
    		 Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-3475
    Investigational medicinal product code
    Other name
    Pembrolizumab
    Pharmaceutical forms
    Concentrate and solvent for solution for injection, Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravascular use
    Dosage and administration details
    Cisplatin 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, 3.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed 500 mg/m^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, and 3.

    Number of subjects in period 1
    		Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Started
    112
    104
    Treated
    112
    102
    Completed
    0
    0
    Not completed
    112
    104
         Consent withdrawn by subject
    3
    3
         Sponsor's Decision
    36
    52
         Death
    71
    49
         Participants Ongoing
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pembrolizumab + cCRT + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

    Reporting group title
    Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Reporting group description
    		 Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

    Reporting group values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin Total
    Number of subjects
    		 112 104 216
    Age categorical
    Units: Participants
        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)
    		 49 55 104
        From 65-84 years
    		 60 49 109
        85 years and over
    		 3 0 3
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.7 ( 9.1 ) 63.2 ( 9.4 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 36 40 76
        Male
    		 76 64 140
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 14 11 25
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 4 5
        White
    		 89 75 164
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 7 14 21
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 3 5
        Not Hispanic or Latino
    		 101 84 185
        Unknown or Not Reported
    		 9 17 26

    End points

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    End points reporting groups
    Reporting group title
    Pembrolizumab + cCRT + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

    Reporting group title
    Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Reporting group description
    		 Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

    Primary: Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis

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    End point title
    		 Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis [1]
    End point description
    Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death. The analysis population consisted of all participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to approximately 3 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Number of subjects analysed
    112
    102
    Units: Percentage of Participants
        number (confidence interval 90%)
    8.0 (4.3 to 13.6)
    6.9 (3.3 to 12.5)
    No statistical analyses for this end point

    Primary: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

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    End point title
    		 Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [2]
    End point description
    ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR). The analysis population consisted of all participants who received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to approximately 3 years
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Number of subjects analysed
    112
    102
    Units: Percentage of Participants
        number (confidence interval 95%)
    71.4 (62.1 to 79.6)
    75.5 (66.0 to 83.5)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

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    End point title
    		 Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    End point description
    PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data. 9999 indicates upper limit not reached at time of data cut-off due to insufficient number of participants with an event. The analysis population consisted of all participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 1/2 years
    End point values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Number of subjects analysed
    112
    102
    Units: Months
        median (confidence interval 95%)
    29.0 (16.6 to 48.5)
    45.3 (17.9 to 9999)
    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 is defined as the time from enrollment to death due to any cause. OS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data. 9999 indicates upper limit not reached at time of data cut-off due to insufficient number of participants with an event. The analysis population consisted of all participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 1/2 years
    End point values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Number of subjects analysed
    112
    102
    Units: Months
        median (confidence interval 95%)
    35.6 (26.1 to 44.2)
    56.7 (41.1 to 9999)
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experienced an Adverse Event (AE)

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    End point title
    		 Number of Participants Who Experienced an Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 a study intervention. The number of participants with at least one AE was assessed. The analysis population consisted of all participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to approximately 1 1/2 years
    End point values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Number of subjects analysed
    112
    102
    Units: Participants
    108
    101
    No statistical analyses for this end point

    Secondary: Number of Participants Who Discontinued From Study Treatment Due to an AE

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    End point title
    		 Number of Participants Who Discontinued From Study Treatment Due to an AE
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 a study intervention. The number of participants who discontinued treatment due to an AE was assessed. The analysis population consisted of all participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to approximately 1 year
    End point values
    		 Pembrolizumab + cCRT + Paclitaxel + Carboplatin Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Number of subjects analysed
    112
    102
    Units: Participants
    48
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For adverse events: Up to ~ 1 1/2 years. All-cause mortality (ACM): Up to ~ 5 1/2 years
    Adverse event reporting additional description
    All-cause mortality includes all enrolled participants. AEs include participants who received ≥1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Pembrolizumab + cCRT + Pemetrexed + Cisplatin
    Reporting group description
    		 Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

    Reporting group title
    Pembrolizumab + cCRT + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

    Serious adverse events
    		 Pembrolizumab + cCRT + Pemetrexed + Cisplatin Pembrolizumab + cCRT + Paclitaxel + Carboplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 102 (45.10%)
    66 / 112 (58.93%)
         number of deaths (all causes)
    49
    72
         number of deaths resulting from adverse events
    7
    12
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Device related thrombosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    7 / 102 (6.86%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    5 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    5 / 102 (4.90%)
    7 / 112 (6.25%)
         occurrences causally related to treatment / all
    5 / 5
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    4 / 4
    Pleural effusion
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    4 / 102 (3.92%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radiation oesophagitis
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 112 (2.68%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation pneumonitis
         subjects affected / exposed
    1 / 102 (0.98%)
    3 / 112 (2.68%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Tracheo-oesophageal fistula
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (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
    Dizziness
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematotoxicity
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 102 (0.00%)
    5 / 112 (4.46%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 102 (2.94%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic epidermal necrolysis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Prerenal failure
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophysitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Hypertrophic osteoarthropathy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    9 / 102 (8.82%)
    14 / 112 (12.50%)
         occurrences causally related to treatment / all
    2 / 11
    2 / 15
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 102 (0.00%)
    4 / 112 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Pembrolizumab + cCRT + Pemetrexed + Cisplatin Pembrolizumab + cCRT + Paclitaxel + Carboplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 102 (98.04%)
    106 / 112 (94.64%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 102 (4.90%)
    6 / 112 (5.36%)
         occurrences all number
    7
    6
    Hypotension
         subjects affected / exposed
    6 / 102 (5.88%)
    11 / 112 (9.82%)
         occurrences all number
    7
    11
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    41 / 102 (40.20%)
    20 / 112 (17.86%)
         occurrences all number
    60
    26
    Chest pain
         subjects affected / exposed
    10 / 102 (9.80%)
    7 / 112 (6.25%)
         occurrences all number
    12
    7
    Chills
         subjects affected / exposed
    3 / 102 (2.94%)
    6 / 112 (5.36%)
         occurrences all number
    3
    6
    Fatigue
         subjects affected / exposed
    33 / 102 (32.35%)
    39 / 112 (34.82%)
         occurrences all number
    38
    49
    Mucosal inflammation
         subjects affected / exposed
    10 / 102 (9.80%)
    6 / 112 (5.36%)
         occurrences all number
    10
    6
    Pyrexia
         subjects affected / exposed
    13 / 102 (12.75%)
    22 / 112 (19.64%)
         occurrences all number
    14
    30
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    29 / 102 (28.43%)
    31 / 112 (27.68%)
         occurrences all number
    37
    36
    Dyspnoea
         subjects affected / exposed
    18 / 102 (17.65%)
    24 / 112 (21.43%)
         occurrences all number
    19
    28
    Oropharyngeal pain
         subjects affected / exposed
    8 / 102 (7.84%)
    2 / 112 (1.79%)
         occurrences all number
    8
    2
    Pleural effusion
         subjects affected / exposed
    2 / 102 (1.96%)
    8 / 112 (7.14%)
         occurrences all number
    2
    8
    Pneumonitis
         subjects affected / exposed
    17 / 102 (16.67%)
    16 / 112 (14.29%)
         occurrences all number
    19
    19
    Productive cough
         subjects affected / exposed
    9 / 102 (8.82%)
    8 / 112 (7.14%)
         occurrences all number
    9
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 102 (6.86%)
    18 / 112 (16.07%)
         occurrences all number
    8
    21
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    8 / 102 (7.84%)
    8 / 112 (7.14%)
         occurrences all number
    9
    9
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 102 (3.92%)
    8 / 112 (7.14%)
         occurrences all number
    6
    8
    Blood creatinine increased
         subjects affected / exposed
    13 / 102 (12.75%)
    6 / 112 (5.36%)
         occurrences all number
    17
    7
    Blood urea increased
         subjects affected / exposed
    7 / 102 (6.86%)
    3 / 112 (2.68%)
         occurrences all number
    9
    3
    Lymphocyte count decreased
         subjects affected / exposed
    8 / 102 (7.84%)
    11 / 112 (9.82%)
         occurrences all number
    12
    16
    Neutrophil count decreased
         subjects affected / exposed
    13 / 102 (12.75%)
    19 / 112 (16.96%)
         occurrences all number
    15
    23
    Platelet count decreased
         subjects affected / exposed
    9 / 102 (8.82%)
    16 / 112 (14.29%)
         occurrences all number
    15
    18
    Weight decreased
         subjects affected / exposed
    14 / 102 (13.73%)
    16 / 112 (14.29%)
         occurrences all number
    14
    16
    White blood cell count decreased
         subjects affected / exposed
    11 / 102 (10.78%)
    11 / 112 (9.82%)
         occurrences all number
    19
    17
    Injury, poisoning and procedural complications
    Radiation oesophagitis
         subjects affected / exposed
    14 / 102 (13.73%)
    13 / 112 (11.61%)
         occurrences all number
    15
    13
    Radiation pneumonitis
         subjects affected / exposed
    12 / 102 (11.76%)
    18 / 112 (16.07%)
         occurrences all number
    12
    18
    Radiation skin injury
         subjects affected / exposed
    8 / 102 (7.84%)
    5 / 112 (4.46%)
         occurrences all number
    8
    5
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    3 / 102 (2.94%)
    8 / 112 (7.14%)
         occurrences all number
    3
    9
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 102 (8.82%)
    9 / 112 (8.04%)
         occurrences all number
    11
    11
    Dysgeusia
         subjects affected / exposed
    8 / 102 (7.84%)
    10 / 112 (8.93%)
         occurrences all number
    8
    11
    Headache
         subjects affected / exposed
    13 / 102 (12.75%)
    9 / 112 (8.04%)
         occurrences all number
    18
    9
    Neuropathy peripheral
         subjects affected / exposed
    5 / 102 (4.90%)
    15 / 112 (13.39%)
         occurrences all number
    5
    15
    Paraesthesia
         subjects affected / exposed
    4 / 102 (3.92%)
    6 / 112 (5.36%)
         occurrences all number
    4
    7
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 102 (0.98%)
    12 / 112 (10.71%)
         occurrences all number
    1
    13
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    33 / 102 (32.35%)
    44 / 112 (39.29%)
         occurrences all number
    40
    53
    Lymphopenia
         subjects affected / exposed
    12 / 102 (11.76%)
    11 / 112 (9.82%)
         occurrences all number
    16
    13
    Neutropenia
         subjects affected / exposed
    23 / 102 (22.55%)
    32 / 112 (28.57%)
         occurrences all number
    29
    50
    Thrombocytopenia
         subjects affected / exposed
    3 / 102 (2.94%)
    17 / 112 (15.18%)
         occurrences all number
    3
    22
    Leukopenia
         subjects affected / exposed
    8 / 102 (7.84%)
    15 / 112 (13.39%)
         occurrences all number
    11
    29
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    11 / 102 (10.78%)
    1 / 112 (0.89%)
         occurrences all number
    13
    1
    Vertigo
         subjects affected / exposed
    3 / 102 (2.94%)
    6 / 112 (5.36%)
         occurrences all number
    3
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 102 (5.88%)
    8 / 112 (7.14%)
         occurrences all number
    7
    8
    Abdominal pain upper
         subjects affected / exposed
    7 / 102 (6.86%)
    3 / 112 (2.68%)
         occurrences all number
    7
    4
    Constipation
         subjects affected / exposed
    27 / 102 (26.47%)
    24 / 112 (21.43%)
         occurrences all number
    32
    28
    Diarrhoea
         subjects affected / exposed
    22 / 102 (21.57%)
    27 / 112 (24.11%)
         occurrences all number
    27
    37
    Dyspepsia
         subjects affected / exposed
    7 / 102 (6.86%)
    15 / 112 (13.39%)
         occurrences all number
    9
    17
    Dysphagia
         subjects affected / exposed
    16 / 102 (15.69%)
    27 / 112 (24.11%)
         occurrences all number
    16
    31
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 102 (5.88%)
    5 / 112 (4.46%)
         occurrences all number
    6
    5
    Nausea
         subjects affected / exposed
    53 / 102 (51.96%)
    28 / 112 (25.00%)
         occurrences all number
    77
    36
    Odynophagia
         subjects affected / exposed
    5 / 102 (4.90%)
    11 / 112 (9.82%)
         occurrences all number
    5
    14
    Oesophagitis
         subjects affected / exposed
    24 / 102 (23.53%)
    17 / 112 (15.18%)
         occurrences all number
    25
    20
    Stomatitis
         subjects affected / exposed
    6 / 102 (5.88%)
    7 / 112 (6.25%)
         occurrences all number
    7
    8
    Vomiting
         subjects affected / exposed
    20 / 102 (19.61%)
    10 / 112 (8.93%)
         occurrences all number
    23
    11
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    2 / 102 (1.96%)
    6 / 112 (5.36%)
         occurrences all number
    2
    6
    Alopecia
         subjects affected / exposed
    6 / 102 (5.88%)
    35 / 112 (31.25%)
         occurrences all number
    6
    35
    Pruritus
         subjects affected / exposed
    16 / 102 (15.69%)
    15 / 112 (13.39%)
         occurrences all number
    18
    19
    Rash
         subjects affected / exposed
    14 / 102 (13.73%)
    22 / 112 (19.64%)
         occurrences all number
    16
    27
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    8 / 102 (7.84%)
    9 / 112 (8.04%)
         occurrences all number
    9
    9
    Hypothyroidism
         subjects affected / exposed
    15 / 102 (14.71%)
    18 / 112 (16.07%)
         occurrences all number
    16
    19
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 102 (10.78%)
    17 / 112 (15.18%)
         occurrences all number
    13
    22
    Back pain
         subjects affected / exposed
    5 / 102 (4.90%)
    6 / 112 (5.36%)
         occurrences all number
    7
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 102 (2.94%)
    6 / 112 (5.36%)
         occurrences all number
    3
    8
    Myalgia
         subjects affected / exposed
    8 / 102 (7.84%)
    11 / 112 (9.82%)
         occurrences all number
    9
    14
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 102 (4.90%)
    12 / 112 (10.71%)
         occurrences all number
    5
    14
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 102 (4.90%)
    8 / 112 (7.14%)
         occurrences all number
    5
    9
    Urinary tract infection
         subjects affected / exposed
    2 / 102 (1.96%)
    7 / 112 (6.25%)
         occurrences all number
    2
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    30 / 102 (29.41%)
    24 / 112 (21.43%)
         occurrences all number
    34
    29
    Dehydration
         subjects affected / exposed
    6 / 102 (5.88%)
    5 / 112 (4.46%)
         occurrences all number
    7
    6
    Hyperglycaemia
         subjects affected / exposed
    6 / 102 (5.88%)
    9 / 112 (8.04%)
         occurrences all number
    11
    13
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 102 (1.96%)
    6 / 112 (5.36%)
         occurrences all number
    2
    8
    Hypokalaemia
         subjects affected / exposed
    6 / 102 (5.88%)
    9 / 112 (8.04%)
         occurrences all number
    8
    10
    Hyponatraemia
         subjects affected / exposed
    3 / 102 (2.94%)
    10 / 112 (8.93%)
         occurrences all number
    5
    15

    More information

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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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