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    Clinical Trial Results:
    AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2021-001075-17
    Trial protocol
    		 ES   AT   PL  
    Global end of trial date
    04 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2025
    First version publication date
    13 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AdvanTIG-205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05014815
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BeiGene
    Sponsor organisation address
    1840 Gateway Drive, San Mateo, CA , United States, 94404
    Public contact
    BeiGene Clinical Support, BeiGene USA, Inc., 1 877-828-5568, ClinicalTrials@beigene.com
    Scientific contact
    BeiGene Clinical Support, BeiGene USA, Inc., 1 877-828-5568, ClinicalTrials@beigene.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
    04 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
    Protection of trial subjects
    This study was conducted in accordance with sponsor procedures, which comply with the principles of Good Clinical Practice (GCP), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines, the Declaration of Helsinki, and applicable local regulatory requirements. The protocol, any amendments, and informed consent forms were reviewed and approved by the Independent Ethics Committee/Institutional Review Board in conformance with GCP and applicable regulatory requirements. Before a patient was enrolled in the study, he or she was provided with a written informed consent form that complied with GCP. The investigator (or designee) explained to each patient the nature of the study, its purpose, procedures, expected duration, and the benefits and risks involved with study participation. Patients were given the opportunity to ask questions and were informed of their right to withdraw from the study at any time without prejudice. After this explanation and before enrolling in the study, patients or their legal representatives signed 2 copies of the informed consent form (one copy for the patient and the other for filing with the patient’s study records). Informed consent was obtained before any screening or study-specific procedures were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 164
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    United States: 27
    Country: Number of subjects enrolled
    Korea, Republic of: 42
    Worldwide total number of subjects
    272
    EEA total number of subjects
    23
    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)
    133
    From 65 to 84 years
    138
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 75 study centers in 8 countries (China, South Korea, United States of America, Australia, France, Spain, Austria, Greece).

    Pre-assignment
    Screening details
    		 Eligible participants were randomized in a 1:1 ratio to receive either ociperlimab or placebo treatment, plus tislelizumab and chemotherapy. Randomization was stratified by histology (squamous versus non--squamous), and programmed cell death protein ligand-1 (PD-L1) expression.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A (O+T+C)
    Arm description
    		 During the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ociperlimab
    Investigational medicinal product code
    BGB-A1217
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    900 mg intravenously (IV) once every 3 weeks (Q3W)

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    BGB-A1217
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg IV Q3W

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle

    Investigational medicinal product name
    Nab paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    75 mg/m², administered intravenously on Day 1 of each 21-day cycle

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    500 mg/m² administered intravenously on Day 1 of each 21-day cycle

    Arm title
    		 Arm B (P+T+C)
    Arm description
    		 During the induction phase, participants received placebo (P) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received placebo 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received placebo IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    Other name
    BGB-A317
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg IV Q3W

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle

    Investigational medicinal product name
    Nab paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    75 mg/m², administered intravenously on Day 1 of each 21-day cycle

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    500 mg/m² administered intravenously on Day 1 of each 21-day cycle

    Number of subjects in period 1
    		Arm A (O+T+C) Arm B (P+T+C)
    Started
    136
    136
    Treated
    135
    136
    Completed
    57
    50
    Not completed
    79
    86
         Consent withdrawn by subject
    10
    10
         Physician decision
    2
    4
         Death
    63
    70
         Lost to follow-up
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A (O+T+C)
    Reporting group description
    		 During the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.

    Reporting group title
    Arm B (P+T+C)
    Reporting group description
    		 During the induction phase, participants received placebo (P) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received placebo 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received placebo IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.

    Reporting group values
    		 Arm A (O+T+C) Arm B (P+T+C) Total
    Number of subjects
    		 136 136 272
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 64.02 ( 8.006 ) 63.77 ( 9.366 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 32 54
        Male
    		 114 104 218
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 4 5
        Not Hispanic or Latino
    		 123 123 246
        Unknown
    		 4 2 6
        Not Reported
    		 8 7 15
    Histology
    Histology stratification refers to the classification of participants based on tumor cell morphology. Squamous histology is defined by malignant transformation of flat epithelial cells typically lining the airways, while nonsquamous histology includes adenocarcinoma, large cell carcinoma, and other subtypes arising from glandular or poorly differentiated epithelial cells.
    Units: Subjects
        Squamous
    		 55 56 111
        Non-Squamous
    		 81 80 161
    PD-L1 Expression
    PD-L1 is a protein that can help cancer cells avoid being killed by the immune system. PD-L1 score was based on the % of tumor area with PD-L1-stained tumor or immune cells, using the TAP (Tumor Area Positive) Score method, previously called vCPS. Scores were obtained via Interactive Response Technology.
    Units: Subjects
        < 1% of tumor cells
    		 57 58 115
        1-49% of Tumor Cells
    		 42 42 84
        > 50% of Tumor Cells
    		 37 36 73

    End points

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    End points reporting groups
    Reporting group title
    Arm A (O+T+C)
    Reporting group description
    		 During the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.

    Reporting group title
    Arm B (P+T+C)
    Reporting group description
    		 During the induction phase, participants received placebo (P) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received placebo 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received placebo IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.

    Primary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Intent-To-Treat Analysis Set
    End point type
    Primary
    End point timeframe
    From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
    End point values
    		 Arm A (O+T+C) Arm B (P+T+C)
    Number of subjects analysed
    136
    136
    Units: Months
        median (confidence interval 95%)
    8.2 (6.2 to 10.6)
    8.1 (6.0 to 10.2)
    Statistical analysis title
    		 Progression-free Survival (PFS)
    Statistical analysis description
    The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (<1% of tumor cells (TC) vs 1-49% TC vs >= 50% TC) and histology (squamous vs non-squamous).
    Comparison groups
    Arm A (O+T+C) v Arm B (P+T+C)
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4698 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.33
    Notes
    [1] - The p-value was calculated using a log-rank test stratified by PD-L1 expression (<1 % TC vs 1 - 49 % TC vs >= 50 % TC) and histology (squamous vs non-squamous).

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Intent-To-Treat Analysis Set
    End point type
    Secondary
    End point timeframe
    From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
    End point values
    		 Arm A (O+T+C) Arm B (P+T+C)
    Number of subjects analysed
    136
    136
    Units: Percentage of Participants
        median (confidence interval 95%)
    41.9 (33.5 to 50.7)
    47.8 (39.2 to 56.5)
    Statistical analysis title
    		 Objective Response Rate (ORR)
    Statistical analysis description
    The Mantel-Haenszel common OR and its 95% CI were estimated using a normal approximation of the log odds ratio and the Robins-Breslow-Greenland variance, stratified by PD-L1 expression and histology.
    Comparison groups
    Arm A (O+T+C) v Arm B (P+T+C)
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.26

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm. The analysis included only intent-to-treat participants with a confirmed complete or partial response per RECIST v1.1.
    End point type
    Secondary
    End point timeframe
    From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
    End point values
    		 Arm A (O+T+C) Arm B (P+T+C)
    Number of subjects analysed
    57
    65
    Units: Months
        median (confidence interval 95%)
    10.4 (8.0 to 17.7)
    11.2 (8.1 to 13.9)
    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 randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
    End point values
    		 Arm A (O+T+C) Arm B (P+T+C)
    Number of subjects analysed
    136
    136
    Units: Months
        median (confidence interval 95%)
    20.6 (14.4 to 99999)
    19.4 (15.4 to 23.1)
    Statistical analysis title
    		 Overall Survival (OS)
    Statistical analysis description
    The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (<1% of tumor cells (TC) vs 1-49% TC vs >= 50% TC) and histology (squamous vs non-squamous).
    Comparison groups
    Arm A (O+T+C) v Arm B (P+T+C)
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.34

    Secondary: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5. The Safety Analysis Set included all randomized participants who received at least one dose of the study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)
    End point values
    		 Arm A (O+T+C) Arm B (P+T+C)
    Number of subjects analysed
    135
    136
    Units: Participants
        Number of participants with any TEAEs
    134
    135
        Number of participants with SAEs
    63
    74
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date (up to 32.4 months).
    Adverse event reporting additional description
    All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Arm A (O+T+C)
    Reporting group description
    		 Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy

    Reporting group title
    Arm B (P+T+C)
    Reporting group description
    		 Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy

    Serious adverse events
    		 Arm A (O+T+C) Arm B (P+T+C)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    74 / 136 (54.41%)
    63 / 135 (46.67%)
         number of deaths (all causes)
    70
    63
         number of deaths resulting from adverse events
    11
    15
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 136 (0.74%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 136 (0.00%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Face oedema
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    2 / 136 (1.47%)
    5 / 135 (3.70%)
         occurrences causally related to treatment / all
    1 / 2
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 136 (0.74%)
    3 / 135 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 136 (1.47%)
    3 / 135 (2.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypoxia
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 136 (1.47%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    4 / 136 (2.94%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 136 (0.74%)
    4 / 135 (2.96%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 136 (0.00%)
    5 / 135 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Immune-mediated lung disease
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 136 (0.74%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    3 / 136 (2.21%)
    5 / 135 (3.70%)
         occurrences causally related to treatment / all
    3 / 3
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    5 / 136 (3.68%)
    3 / 135 (2.22%)
         occurrences causally related to treatment / all
    5 / 5
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    4 / 136 (2.94%)
    5 / 135 (3.70%)
         occurrences causally related to treatment / all
    4 / 4
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated myocarditis
         subjects affected / exposed
    2 / 136 (1.47%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated encephalitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         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
    Anaemia
         subjects affected / exposed
    5 / 136 (3.68%)
    4 / 135 (2.96%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 136 (0.74%)
    3 / 135 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 136 (2.94%)
    4 / 135 (2.96%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Thrombocytopenia
         subjects affected / exposed
    2 / 136 (1.47%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 136 (1.47%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 136 (1.47%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 136 (1.47%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated pancreatitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated enterocolitis
         subjects affected / exposed
    3 / 136 (2.21%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated hepatitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatic failure
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated dermatitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudocellulitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated nephritis
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated myositis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    4 / 136 (2.94%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal peritonitis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematological infection
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    13 / 136 (9.56%)
    10 / 135 (7.41%)
         occurrences causally related to treatment / all
    4 / 15
    4 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Neutropenic sepsis
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Kidney infection
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Influenza
         subjects affected / exposed
    2 / 136 (1.47%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 136 (1.47%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 136 (0.74%)
    2 / 135 (1.48%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 135 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 135 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Arm A (O+T+C) Arm B (P+T+C)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    132 / 136 (97.06%)
    132 / 135 (97.78%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    6 / 136 (4.41%)
    3 / 135 (2.22%)
         occurrences all number
    6
    3
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 136 (2.21%)
    6 / 135 (4.44%)
         occurrences all number
    3
    6
    Hypertension
         subjects affected / exposed
    5 / 136 (3.68%)
    4 / 135 (2.96%)
         occurrences all number
    5
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    18 / 136 (13.24%)
    12 / 135 (8.89%)
         occurrences all number
    28
    19
    Fatigue
         subjects affected / exposed
    24 / 136 (17.65%)
    27 / 135 (20.00%)
         occurrences all number
    31
    40
    Malaise
         subjects affected / exposed
    9 / 136 (6.62%)
    3 / 135 (2.22%)
         occurrences all number
    9
    3
    Oedema peripheral
         subjects affected / exposed
    19 / 136 (13.97%)
    11 / 135 (8.15%)
         occurrences all number
    22
    13
    Pyrexia
         subjects affected / exposed
    20 / 136 (14.71%)
    18 / 135 (13.33%)
         occurrences all number
    30
    22
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 136 (15.44%)
    25 / 135 (18.52%)
         occurrences all number
    23
    32
    Dyspnoea
         subjects affected / exposed
    12 / 136 (8.82%)
    14 / 135 (10.37%)
         occurrences all number
    13
    18
    Haemoptysis
         subjects affected / exposed
    8 / 136 (5.88%)
    8 / 135 (5.93%)
         occurrences all number
    8
    17
    Pleural effusion
         subjects affected / exposed
    3 / 136 (2.21%)
    6 / 135 (4.44%)
         occurrences all number
    3
    6
    Productive cough
         subjects affected / exposed
    8 / 136 (5.88%)
    11 / 135 (8.15%)
         occurrences all number
    9
    12
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 136 (3.68%)
    2 / 135 (1.48%)
         occurrences all number
    5
    2
    Insomnia
         subjects affected / exposed
    13 / 136 (9.56%)
    16 / 135 (11.85%)
         occurrences all number
    13
    17
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    6 / 136 (4.41%)
    3 / 135 (2.22%)
         occurrences all number
    6
    4
    Alanine aminotransferase increased
         subjects affected / exposed
    43 / 136 (31.62%)
    41 / 135 (30.37%)
         occurrences all number
    67
    69
    Aspartate aminotransferase increased
         subjects affected / exposed
    37 / 136 (27.21%)
    40 / 135 (29.63%)
         occurrences all number
    57
    75
    Bilirubin conjugated increased
         subjects affected / exposed
    6 / 136 (4.41%)
    4 / 135 (2.96%)
         occurrences all number
    6
    5
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 136 (4.41%)
    4 / 135 (2.96%)
         occurrences all number
    9
    6
    Blood bilirubin increased
         subjects affected / exposed
    14 / 136 (10.29%)
    8 / 135 (5.93%)
         occurrences all number
    15
    17
    Blood creatinine increased
         subjects affected / exposed
    22 / 136 (16.18%)
    10 / 135 (7.41%)
         occurrences all number
    25
    10
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    8 / 136 (5.88%)
    11 / 135 (8.15%)
         occurrences all number
    10
    19
    Blood urea increased
         subjects affected / exposed
    5 / 136 (3.68%)
    3 / 135 (2.22%)
         occurrences all number
    5
    4
    Fibrin D dimer increased
         subjects affected / exposed
    2 / 136 (1.47%)
    5 / 135 (3.70%)
         occurrences all number
    2
    6
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    13 / 136 (9.56%)
    5 / 135 (3.70%)
         occurrences all number
    17
    8
    Lymphocyte count decreased
         subjects affected / exposed
    12 / 136 (8.82%)
    22 / 135 (16.30%)
         occurrences all number
    47
    52
    Neutrophil count decreased
         subjects affected / exposed
    50 / 136 (36.76%)
    59 / 135 (43.70%)
         occurrences all number
    175
    188
    Neutrophil count increased
         subjects affected / exposed
    5 / 136 (3.68%)
    4 / 135 (2.96%)
         occurrences all number
    7
    6
    Platelet count decreased
         subjects affected / exposed
    37 / 136 (27.21%)
    51 / 135 (37.78%)
         occurrences all number
    64
    107
    SARS-CoV-2 test positive
         subjects affected / exposed
    16 / 136 (11.76%)
    13 / 135 (9.63%)
         occurrences all number
    17
    15
    Weight decreased
         subjects affected / exposed
    18 / 136 (13.24%)
    16 / 135 (11.85%)
         occurrences all number
    18
    20
    Weight increased
         subjects affected / exposed
    14 / 136 (10.29%)
    18 / 135 (13.33%)
         occurrences all number
    17
    23
    White blood cell count decreased
         subjects affected / exposed
    54 / 136 (39.71%)
    61 / 135 (45.19%)
         occurrences all number
    166
    196
    Cardiac disorders
    Supraventricular extrasystoles
         subjects affected / exposed
    4 / 136 (2.94%)
    5 / 135 (3.70%)
         occurrences all number
    7
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 136 (5.15%)
    12 / 135 (8.89%)
         occurrences all number
    7
    16
    Dysgeusia
         subjects affected / exposed
    4 / 136 (2.94%)
    7 / 135 (5.19%)
         occurrences all number
    5
    7
    Headache
         subjects affected / exposed
    12 / 136 (8.82%)
    12 / 135 (8.89%)
         occurrences all number
    13
    16
    Hypoaesthesia
         subjects affected / exposed
    2 / 136 (1.47%)
    7 / 135 (5.19%)
         occurrences all number
    2
    7
    Paraesthesia
         subjects affected / exposed
    5 / 136 (3.68%)
    0 / 135 (0.00%)
         occurrences all number
    5
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    12 / 136 (8.82%)
    8 / 135 (5.93%)
         occurrences all number
    13
    8
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    13 / 136 (9.56%)
    11 / 135 (8.15%)
         occurrences all number
    40
    42
    Anaemia
         subjects affected / exposed
    81 / 136 (59.56%)
    90 / 135 (66.67%)
         occurrences all number
    142
    175
    Neutropenia
         subjects affected / exposed
    11 / 136 (8.09%)
    12 / 135 (8.89%)
         occurrences all number
    21
    19
    Lymphopenia
         subjects affected / exposed
    5 / 136 (3.68%)
    3 / 135 (2.22%)
         occurrences all number
    20
    11
    Thrombocytopenia
         subjects affected / exposed
    8 / 136 (5.88%)
    13 / 135 (9.63%)
         occurrences all number
    22
    17
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 136 (0.74%)
    6 / 135 (4.44%)
         occurrences all number
    1
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 136 (9.56%)
    5 / 135 (3.70%)
         occurrences all number
    14
    5
    Constipation
         subjects affected / exposed
    40 / 136 (29.41%)
    45 / 135 (33.33%)
         occurrences all number
    56
    65
    Diarrhoea
         subjects affected / exposed
    25 / 136 (18.38%)
    21 / 135 (15.56%)
         occurrences all number
    28
    27
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 136 (3.68%)
    4 / 135 (2.96%)
         occurrences all number
    5
    6
    Nausea
         subjects affected / exposed
    51 / 136 (37.50%)
    38 / 135 (28.15%)
         occurrences all number
    98
    50
    Stomatitis
         subjects affected / exposed
    8 / 136 (5.88%)
    14 / 135 (10.37%)
         occurrences all number
    8
    15
    Vomiting
         subjects affected / exposed
    30 / 136 (22.06%)
    24 / 135 (17.78%)
         occurrences all number
    59
    36
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    26 / 136 (19.12%)
    25 / 135 (18.52%)
         occurrences all number
    28
    25
    Pruritus
         subjects affected / exposed
    8 / 136 (5.88%)
    29 / 135 (21.48%)
         occurrences all number
    10
    44
    Rash
         subjects affected / exposed
    27 / 136 (19.85%)
    42 / 135 (31.11%)
         occurrences all number
    43
    62
    Rash maculo-papular
         subjects affected / exposed
    4 / 136 (2.94%)
    5 / 135 (3.70%)
         occurrences all number
    4
    5
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    16 / 136 (11.76%)
    21 / 135 (15.56%)
         occurrences all number
    18
    23
    Hyperthyroidism
         subjects affected / exposed
    8 / 136 (5.88%)
    10 / 135 (7.41%)
         occurrences all number
    10
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 136 (7.35%)
    6 / 135 (4.44%)
         occurrences all number
    13
    10
    Muscular weakness
         subjects affected / exposed
    5 / 136 (3.68%)
    7 / 135 (5.19%)
         occurrences all number
    5
    7
    Myalgia
         subjects affected / exposed
    5 / 136 (3.68%)
    5 / 135 (3.70%)
         occurrences all number
    6
    8
    Pain in extremity
         subjects affected / exposed
    9 / 136 (6.62%)
    10 / 135 (7.41%)
         occurrences all number
    10
    18
    Back pain
         subjects affected / exposed
    8 / 136 (5.88%)
    8 / 135 (5.93%)
         occurrences all number
    8
    8
    Infections and infestations
    COVID-19
         subjects affected / exposed
    15 / 136 (11.03%)
    20 / 135 (14.81%)
         occurrences all number
    24
    24
    Pneumonia
         subjects affected / exposed
    14 / 136 (10.29%)
    12 / 135 (8.89%)
         occurrences all number
    14
    18
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 136 (6.62%)
    9 / 135 (6.67%)
         occurrences all number
    11
    11
    Urinary tract infection
         subjects affected / exposed
    5 / 136 (3.68%)
    4 / 135 (2.96%)
         occurrences all number
    6
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    42 / 136 (30.88%)
    37 / 135 (27.41%)
         occurrences all number
    55
    42
    Dehydration
         subjects affected / exposed
    6 / 136 (4.41%)
    4 / 135 (2.96%)
         occurrences all number
    40
    25
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 136 (0.74%)
    5 / 135 (3.70%)
         occurrences all number
    3
    8
    Hyperglycaemia
         subjects affected / exposed
    16 / 136 (11.76%)
    13 / 135 (9.63%)
         occurrences all number
    19
    28
    Hypertriglyceridaemia
         subjects affected / exposed
    5 / 136 (3.68%)
    7 / 135 (5.19%)
         occurrences all number
    8
    21
    Hyperuricaemia
         subjects affected / exposed
    8 / 136 (5.88%)
    3 / 135 (2.22%)
         occurrences all number
    18
    4
    Hypoalbuminaemia
         subjects affected / exposed
    23 / 136 (16.91%)
    30 / 135 (22.22%)
         occurrences all number
    34
    53
    Hypocalcaemia
         subjects affected / exposed
    6 / 136 (4.41%)
    7 / 135 (5.19%)
         occurrences all number
    9
    10
    Hypokalaemia
         subjects affected / exposed
    17 / 136 (12.50%)
    23 / 135 (17.04%)
         occurrences all number
    24
    36
    Hypomagnesaemia
         subjects affected / exposed
    6 / 136 (4.41%)
    6 / 135 (4.44%)
         occurrences all number
    8
    11
    Hyponatraemia
         subjects affected / exposed
    21 / 136 (15.44%)
    20 / 135 (14.81%)
         occurrences all number
    26
    36
    Hypophosphataemia
         subjects affected / exposed
    4 / 136 (2.94%)
    5 / 135 (3.70%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2021
    Original Protocol
    11 Jun 2021
    Amendment 1.0
    30 Mar 2022
    Amendment 2.0
    23 Sep 2022
    Amendment 3.0

    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.
    NA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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