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    Clinical Trial Results:
    A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non Squamous Non Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2018-002147-28
    Trial protocol
    		 PT   HU   BG   PL   HR  
    Global end of trial date
    19 Sep 2023

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P16 3.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03676192
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CELLTRION, Inc.
    Sponsor organisation address
    23 Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of,
    Public contact
    CELLTRION, Inc., CELLTRION, Inc., 82 328505000, contact@celltrion.com
    Scientific contact
    CELLTRION, Inc., CELLTRION, Inc., 82 328505000, contact@celltrion.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
    27 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by ORR up to Cycle 6 during the Induction Study Period
    Protection of trial subjects
    The study was conducted according to the principles of ICH E6 (R2). The investigator conducted all aspects of this study in accordance with all national, state, and local laws or regulations. Safety assessments were performed on immunogenicity, hypersensitivity monitoring (via vital sign and ECG), vital sign measurements (blood pressure, heart rates, respiratory rates and body temperature), weight, viral assessment, physical examination, clinical laboratory analyses, ECG, ECOG, AEs (including SAEs), adverse events of special interest (AESIs) (hypersensitivity/infusion-related reactions, gastrointestinal perforations and fistulae, wound healing complications, hypertension, posterior reversible encephalopathy syndrome [PRES], proteinuria, arterial thromboembolism [ATE], venous thromboembolism [VTE], hemorrhages, congestive heart failure [CHF] and ovarian failure/fertility), pregnancy testing, prior and concomitant medications throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 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
    Poland: 12
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Romania: 37
    Country: Number of subjects enrolled
    Croatia: 4
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Belarus: 22
    Country: Number of subjects enrolled
    Brazil: 30
    Country: Number of subjects enrolled
    Chile: 23
    Country: Number of subjects enrolled
    Georgia: 34
    Country: Number of subjects enrolled
    India: 51
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 15
    Country: Number of subjects enrolled
    Malaysia: 9
    Country: Number of subjects enrolled
    Mexico: 48
    Country: Number of subjects enrolled
    Peru: 20
    Country: Number of subjects enrolled
    Russian Federation: 118
    Country: Number of subjects enrolled
    Serbia: 58
    Country: Number of subjects enrolled
    Thailand: 10
    Country: Number of subjects enrolled
    Ukraine: 147
    Country: Number of subjects enrolled
    Viet Nam: 22
    Worldwide total number of subjects
    689
    EEA total number of subjects
    77
    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)
    416
    From 65 to 84 years
    273
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 164 study centers were included in 21 countries. In these study centers, there were 1,530 screened patients and 689 randomly assigned patients to treatment. The first patient randomly assiged to treatment was 01 February 2019.

    Pre-assignment
    Screening details
    		 Patients with metastatic or recurrent non-sqamous non-small cell lung cancer were enrolled and randomly assigned in a 1:1 ratio to CT-P16 or EU-approved Avastin.

    Period 1
    Period 1 title
    Induction Study Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P16
    Arm description
    		 During the Induction Study Period, patients received CT-P16 every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, CT-P16 as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg intravenous (IV) of CT-P16 was be administered on Day 1 of each cycle and will be repeated every 3 weeks until 6 cycles.

    Arm title
    		 EU-approved Avastin
    Arm description
    		 During the Induction Study Period, patients received EU-approved Avastin every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, EU-approved Avastin as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg intravenous (IV) of EU-approved Avastin was be administered on Day 1 of each cycle and will be repeated every 3 weeks until 6 cycles.

    Number of subjects in period 1
    		CT-P16 EU-approved Avastin
    Started
    342
    347
    Completed
    258
    241
    Not completed
    84
    106
         Consent withdrawn by subject
    15
    20
         Physician decision
    3
    6
         Death
    20
    23
         Progressive Disease
    21
    32
         Adverse Events
    20
    21
         Lost to follow-up
    3
    3
         Protocol deviation
    2
    1
    Period 2
    Period 2 title
    Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P16
    Arm description
    		 During the Induction Study Period, patients received CT-P16 every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, CT-P16 as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg intravenous (IV) of CT-P16 was be administered on Day 1 of each cycle and will be repeated every 3 weeks until 6 cycles.

    Arm title
    		 EU-approved Avastin
    Arm description
    		 During the Induction Study Period, patients received EU-approved Avastin every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, EU-approved Avastin as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg intravenous (IV) of EU-approved Avastin was be administered on Day 1 of each cycle and will be repeated every 3 weeks until 6 cycles.

    Number of subjects in period 2 [1]
    		CT-P16 EU-approved Avastin
    Started
    239
    227
    Completed
    0
    0
    Not completed
    239
    227
         Consent withdrawn by subject
    6
    16
         Physician decision
    12
    16
         Others
    9
    8
         Death
    14
    17
         Progressive Disease
    173
    152
         Adverse Events
    21
    16
         Lost to follow-up
    3
    -
         Protocol deviation
    1
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 33 patients (19 patients in the CT-P16 group and 14 patients in the EU-approved Avastin treatment group) who completed the Induction Study period did not initate the Maintenance Study Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P16
    Reporting group description
    		 During the Induction Study Period, patients received CT-P16 every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, CT-P16 as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.

    Reporting group title
    EU-approved Avastin
    Reporting group description
    		 During the Induction Study Period, patients received EU-approved Avastin every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, EU-approved Avastin as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.

    Reporting group values
    		 CT-P16 EU-approved Avastin Total
    Number of subjects
    		 342 347 689
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 203 213 416
        From 65-84 years
    		 139 134 273
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (32 to 82) 62 (26 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 119 125 244
        Male
    		 223 222 445
    Subject analysis sets

    Subject analysis set title
    Intent-to-treat Population (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. Patients were assigned to treatment groups based on randomization.

    Subject analysis sets values
    		 Intent-to-treat Population (ITT)
    Number of subjects
    689
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    416
        From 65-84 years
    273
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    CT-P16
    Reporting group description
    		 During the Induction Study Period, patients received CT-P16 every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, CT-P16 as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.

    Reporting group title
    EU-approved Avastin
    Reporting group description
    		 During the Induction Study Period, patients received EU-approved Avastin every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, EU-approved Avastin as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.
    Reporting group title
    CT-P16
    Reporting group description
    		 During the Induction Study Period, patients received CT-P16 every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, CT-P16 as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.

    Reporting group title
    EU-approved Avastin
    Reporting group description
    		 During the Induction Study Period, patients received EU-approved Avastin every 3 weeks up to 6 cycles with paclitaxel and carboplatin. After the Induction Study Period, EU-approved Avastin as a monotherapy was maintained every 3 weeks until either PD or intolerable toxicity occurrence, whichever occurred first.

    Subject analysis set title
    Intent-to-treat Population (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. Patients were assigned to treatment groups based on randomization.

    Primary: Objective response rate during the Induction Study Period

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    End point title
    		 Objective response rate during the Induction Study Period
    End point description
    Tumor responses were be measured and recorded by using RECIST v.1.1. Tumor assessment were assessed at Screening and every 2 cycles (end of Cycle 2, Cycle 4, and Cycle 6) during the Induction Study Period
    End point type
    Primary
    End point timeframe
    ORR up to Cycle 6 during the Induction Study Period
    End point values
    		 CT-P16 EU-approved Avastin
    Number of subjects analysed
    342
    347
    Units: Objective response rate
    145
    146
    Statistical analysis title
    		 Objective Response Rate
    Comparison groups
    CT-P16 v EU-approved Avastin
    Number of subjects included in analysis
    689
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.02
         upper limit
    		 7.83

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed from the date the informed consent form is signed until up to 28 days from last dose of study drug, regardless of the relationship to the study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    CT-P16
    Reporting group description
    		 The Safety population consisted of all randomly assigned patients who received at least 1 dose (partial or full) of study drug (CT-P16 or EU-approved Avastin)

    Reporting group title
    EU-approved Avastin
    Reporting group description
    		 The Safety population consisted of all randomly assigned patients who received at least 1 dose (partial or full) of study drug (CT-P16 or EU-approved Avastin)

    Serious adverse events
    		 CT-P16 EU-approved Avastin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 345 (20.58%)
    75 / 344 (21.80%)
         number of deaths (all causes)
    230
    236
         number of deaths resulting from adverse events
    24
    25
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (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 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    3 / 345 (0.87%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    2 / 345 (0.58%)
    3 / 344 (0.87%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Fatigue
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia malignant
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 345 (0.58%)
    3 / 344 (0.87%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 2
    1 / 3
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media reaction
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagobronchial fistula
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal disorder
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 345 (0.58%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    5 / 345 (1.45%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    4 / 345 (1.16%)
    3 / 344 (0.87%)
         occurrences causally related to treatment / all
    2 / 4
    3 / 3
         deaths causally related to treatment / all
    2 / 4
    2 / 2
    Respiratory distress
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (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
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal nerve dysfunction
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         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
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiac failure acute
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Headache
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuralgia
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological symptom
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 345 (0.58%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    6 / 345 (1.74%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    5 / 345 (1.45%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 345 (0.58%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    2 / 345 (0.58%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal haemorrhage
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic pseudocyst rupture
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         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 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    5 / 345 (1.45%)
    5 / 344 (1.45%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Infectious pleural effusion
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (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 / 345 (0.29%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pneumonia
         subjects affected / exposed
    9 / 345 (2.61%)
    10 / 344 (2.91%)
         occurrences causally related to treatment / all
    0 / 9
    2 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (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
    3 / 345 (0.87%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Septic shock
         subjects affected / exposed
    3 / 345 (0.87%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    2 / 2
    1 / 2
    Urinary tract infection
         subjects affected / exposed
    2 / 345 (0.58%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 345 (0.29%)
    3 / 344 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 345 (0.58%)
    2 / 344 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 344 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 344 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CT-P16 EU-approved Avastin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    316 / 345 (91.59%)
    299 / 344 (86.92%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    24 / 345 (6.96%)
    19 / 344 (5.52%)
         occurrences all number
    37
    30
    Aspartate aminotransferase increased
         subjects affected / exposed
    23 / 345 (6.67%)
    17 / 344 (4.94%)
         occurrences all number
    35
    24
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    22 / 345 (6.38%)
    19 / 344 (5.52%)
         occurrences all number
    25
    23
    Neutrophil count decreased
         subjects affected / exposed
    15 / 345 (4.35%)
    19 / 344 (5.52%)
         occurrences all number
    20
    36
    Platelet count decreased
         subjects affected / exposed
    29 / 345 (8.41%)
    23 / 344 (6.69%)
         occurrences all number
    48
    33
    Weight decreased
         subjects affected / exposed
    34 / 345 (9.86%)
    31 / 344 (9.01%)
         occurrences all number
    47
    38
    Vascular disorders
    Hypertension
         subjects affected / exposed
    36 / 345 (10.43%)
    33 / 344 (9.59%)
         occurrences all number
    48
    49
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 345 (7.25%)
    20 / 344 (5.81%)
         occurrences all number
    30
    28
    Neuropathy peripheral
         subjects affected / exposed
    52 / 345 (15.07%)
    50 / 344 (14.53%)
         occurrences all number
    67
    59
    Paraesthesia
         subjects affected / exposed
    35 / 345 (10.14%)
    29 / 344 (8.43%)
         occurrences all number
    51
    40
    Peripheral sensory neuropathy
         subjects affected / exposed
    35 / 345 (10.14%)
    35 / 344 (10.17%)
         occurrences all number
    46
    43
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    109 / 345 (31.59%)
    93 / 344 (27.03%)
         occurrences all number
    147
    140
    Leukopenia
         subjects affected / exposed
    30 / 345 (8.70%)
    23 / 344 (6.69%)
         occurrences all number
    44
    41
    Neutropenia
         subjects affected / exposed
    70 / 345 (20.29%)
    54 / 344 (15.70%)
         occurrences all number
    123
    90
    Thrombocytopenia
         subjects affected / exposed
    62 / 345 (17.97%)
    48 / 344 (13.95%)
         occurrences all number
    101
    77
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    63 / 345 (18.26%)
    54 / 344 (15.70%)
         occurrences all number
    107
    90
    Fatigue
         subjects affected / exposed
    45 / 345 (13.04%)
    40 / 344 (11.63%)
         occurrences all number
    75
    56
    Pyrexia
         subjects affected / exposed
    22 / 345 (6.38%)
    17 / 344 (4.94%)
         occurrences all number
    37
    26
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    38 / 345 (11.01%)
    33 / 344 (9.59%)
         occurrences all number
    43
    41
    Diarrhoea
         subjects affected / exposed
    44 / 345 (12.75%)
    47 / 344 (13.66%)
         occurrences all number
    61
    64
    Nausea
         subjects affected / exposed
    74 / 345 (21.45%)
    64 / 344 (18.60%)
         occurrences all number
    116
    99
    Vomiting
         subjects affected / exposed
    30 / 345 (8.70%)
    30 / 344 (8.72%)
         occurrences all number
    38
    34
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    17 / 345 (4.93%)
    24 / 344 (6.98%)
         occurrences all number
    21
    25
    Dyspnoea
         subjects affected / exposed
    23 / 345 (6.67%)
    20 / 344 (5.81%)
         occurrences all number
    30
    22
    Epistaxis
         subjects affected / exposed
    14 / 345 (4.06%)
    19 / 344 (5.52%)
         occurrences all number
    19
    22
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    220 / 345 (63.77%)
    218 / 344 (63.37%)
         occurrences all number
    266
    261
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    44 / 345 (12.75%)
    44 / 344 (12.79%)
         occurrences all number
    68
    78
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    36 / 345 (10.43%)
    30 / 344 (8.72%)
         occurrences all number
    73
    38
    Myalgia
         subjects affected / exposed
    16 / 345 (4.64%)
    18 / 344 (5.23%)
         occurrences all number
    22
    37
    Pain in extremity
         subjects affected / exposed
    18 / 345 (5.22%)
    20 / 344 (5.81%)
         occurrences all number
    35
    28
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    19 / 345 (5.51%)
    7 / 344 (2.03%)
         occurrences all number
    29
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    43 / 345 (12.46%)
    42 / 344 (12.21%)
         occurrences all number
    56
    52

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2019
    Updated to allow 8 weeks of screening period for patients with CNS metastases to provide sufficient time for CNS treatment. Updated to clarify the prohibited therapy.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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