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    Clinical Trial Results:
    A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment with BIBF 1120 Following Chemotherapy in Patients with Relapsed Ovarian Cancer

    Summary
    EudraCT number
    		 2005-002427-14
    Trial protocol
    		 GB  
    Global end of trial date
    18 Mar 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 May 2019
    First version publication date
    01 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Updates in synopsis
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    1199.9
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00710762
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim Pharma GmbH & Co. KG, +1 800243 0127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim Pharma GmbH & Co. KG, +1 800243 0127, clintriage.rdg@boehringer-ingelheim.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
    17 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. If a subject continued to take trial medication, close monitoring was adhered to and all adverse events recorded. Rules were implemented in all trials whereby doses would be reduced if required. Thereafter, if further events were reported, the subject would be withdrawn from the trial. Symptomatic treatment of tumour associated symptoms were allowed throughout.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2006
    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
    United Kingdom: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    59
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 84 randomised patients, 43 Nintedanib and 40 placebo treated patients were included in all analyses. 1 patient was excluded from analyses as she had received both trial treatments at different times(she was randomised to placebo but was initially treated for 1 treatment cycle with Nintedanib due to a dispensing error then 2 treatment cycles)

    Period 1
    Period 1 title
    Treatment period (overall 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
    		 Nintedanib
    Arm description
    		 Patients were treated with 250mg nintedanib twice daily. 43 patients were included in the analyses instead of 44 patients in nintedanib arm as one patient was excluded after drug administration due to important protocol violation. Consequently, number of subjects that started is 44 but only 43 reported (to match the numbers in the baseline characteristics)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIBF 1120
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated with 250mg nintedanib twice daily

    Arm title
    		 Placebo
    Arm description
    		 Patients were treated with matching placebo twice daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated with matching placebo twice daily

    Number of subjects in period 1 [1]
    		Nintedanib Placebo
    Started
    43
    40
    Completed
    5
    0
    Not completed
    38
    40
         Adverse Event other disease worsening
    2
    1
         Other Adverse Event
    7
    7
         Reason other than those listed
    1
    2
         Lost to follow-up
    1
    -
         Progressive disease
    27
    30
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on the patients who were randomised after successfully completing the screening period and received at least one of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nintedanib
    Reporting group description
    		 Patients were treated with 250mg nintedanib twice daily. 43 patients were included in the analyses instead of 44 patients in nintedanib arm as one patient was excluded after drug administration due to important protocol violation. Consequently, number of subjects that started is 44 but only 43 reported (to match the numbers in the baseline characteristics)

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were treated with matching placebo twice daily

    Reporting group values
    		 Nintedanib Placebo Total
    Number of subjects
    		 43 40 83
    Age categorical
    Units: Subjects
    Age continuous
    One patient in the placebo arm has been excl
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ( 9.5 ) 61.3 ( 9.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 40 83
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Nintedanib
    Reporting group description
    		 Patients were treated with 250mg nintedanib twice daily. 43 patients were included in the analyses instead of 44 patients in nintedanib arm as one patient was excluded after drug administration due to important protocol violation. Consequently, number of subjects that started is 44 but only 43 reported (to match the numbers in the baseline characteristics)

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were treated with matching placebo twice daily

    Primary: PFS Rate at 36 Weeks (After 9 Months)

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    End point title
    		 PFS Rate at 36 Weeks (After 9 Months) [1]
    End point description
    The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan- Meier estimated percent probability.
    End point type
    Primary
    End point timeframe
    36 weeks (after 9 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothiesis test were tested.
    End point values
    		 Nintedanib Placebo
    Number of subjects analysed
    43 [2]
    40 [3]
    Units: percent probability of PFS
        median (confidence interval 95%)
    15.6 (3.8 to 27.3)
    2.9 (0 to 8.4)
    Notes
    [2] - Treated set.
    [3] - Treated set.
    No statistical analyses for this end point

    Secondary: Time to Tumour Progression

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    End point title
    		 Time to Tumour Progression
    End point description
    Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels. For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria: Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart, or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD.
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 Nintedanib Placebo
    Number of subjects analysed
    43 [4]
    40 [5]
    Units: days
    median (confidence interval 95%)
        according to RECIST and CA-125
    83 (78 to 149)
    84 (78 to 87)
        according to CA-125
    85 (79 to 149)
    86 (67 to 113)
        according to RECIST
    143 (82 to 175)
    85 (78 to 89)
    Notes
    [4] - Treated set
    [5] - Treated set
    No statistical analyses for this end point

    Secondary: Time to Death

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    End point title
    		 Time to Death
    End point description
    This end point was not determined as no patients died during the trial.
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 Nintedanib Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [6] - This end point was not determined as no patients died during the trial.
    [7] - This end point was not determined as no patients died during the trial.
    No statistical analyses for this end point

    Secondary: Incidence and Intensity of Adverse Events With Grading According CTCAE

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    End point title
    		 Incidence and Intensity of Adverse Events With Grading According CTCAE
    End point description
    Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
    End point type
    Secondary
    End point timeframe
    First drug administration until 28 days after last drug administration,up until 309 days
    End point values
    		 Nintedanib Placebo
    Number of subjects analysed
    43 [8]
    40 [9]
    Units: percentage of participants
    number (not applicable)
        CTCAE grade 1
    2.3
    25
        CTCAE grade 2
    34.9
    42.5
        CTCAE grade 3
    53.5
    25
        CTCAE grade 4
    7
    2.5
        CTCAE grade 5
    0
    0
    Notes
    [8] - Treated set
    [9] - Treated set
    No statistical analyses for this end point

    Secondary: PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)

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    End point title
    		 PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
    End point description
    The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan- Meier estimated percent probability.
    End point type
    Secondary
    End point timeframe
    12 weeks (after 3 months) and 24 weeks ( after 6 months)
    End point values
    		 Nintedanib Placebo
    Number of subjects analysed
    43 [10]
    40 [11]
    Units: percent probability of PFS
    median (confidence interval 95%)
        at 24 weeks ( after 6 months)
    26.7 (12.5 to 40.8)
    17.3 (5.2 to 29.4)
        at 12 weeks (after 3 months)
    45.3 (29.5 to 61.2)
    46.2 (30.5 to 61.8)
    Notes
    [10] - Treated set
    [11] - Treated set
    No statistical analyses for this end point

    Secondary: Clinical Relevant Abnormalities for Laboratory Parameters

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    End point title
    		 Clinical Relevant Abnormalities for Laboratory Parameters
    End point description
    Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
    End point type
    Secondary
    End point timeframe
    First drug administration until 28 days after last drug administration, up until 309 days
    End point values
    		 Nintedanib Placebo
    Number of subjects analysed
    43 [12]
    40 [13]
    Units: Percentage of participants
    number (not applicable)
        Alanine aminotransferase increased
    37.2
    7.5
        Gamma-glutamyltransferase increased
    30.2
    2.5
        Aspartate aminotransferase increased
    25.6
    2.5
        Blood alkaline phosphatase increased
    7
    5
        Blood lactate dehydrogenase increased
    4.7
    0
        Blood alkaline phosphatase
    0
    2.5
        Blood alkaline phosphatase abnormal
    2.3
    2.5
        Lymphocyte count decreased
    0
    2.5
        Vitamin B12 decreased
    0
    2.5
        Alanine aminotransferase abnormal
    2.3
    0
        Blood lactate dehydrogenase abnormal
    2.3
    0
        Gamma-glutamyltransferase abnormal
    2.3
    0
        Neutrophil count decreased
    2.3
    0
        White blood cells urine positive
    2.3
    0
        Blood pressure increased
    0
    2.5
        Electrocardiogram T wave amplitude decreased
    0
    2.5
        Liver function test abnormal
    2.3
    0
    Notes
    [12] - Treated set
    [13] - Treated set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First drug administration until 28 days after last drug administration, up until 309 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Nintedanib
    Reporting group description
    		 Patients were treated with 250mg nintedanib twice daily

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were treated with matching placebo twice daily

    Serious adverse events
    		 Nintedanib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 43 (32.56%)
    10 / 40 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    6 / 43 (13.95%)
    5 / 40 (12.50%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleuritic pain
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mood altered
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Catheter related infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 40 (2.50%)
         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
    		 Nintedanib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 43 (97.67%)
    37 / 40 (92.50%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    16 / 43 (37.21%)
    3 / 40 (7.50%)
         occurrences all number
    20
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 43 (23.26%)
    1 / 40 (2.50%)
         occurrences all number
    12
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    12 / 43 (27.91%)
    1 / 40 (2.50%)
         occurrences all number
    12
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 43 (11.63%)
    2 / 40 (5.00%)
         occurrences all number
    5
    2
    Hot flush
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 40 (7.50%)
         occurrences all number
    3
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 40 (10.00%)
         occurrences all number
    4
    4
    Headache
         subjects affected / exposed
    6 / 43 (13.95%)
    4 / 40 (10.00%)
         occurrences all number
    6
    4
    Lethargy
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 40 (10.00%)
         occurrences all number
    4
    4
    Paraesthesia
         subjects affected / exposed
    1 / 43 (2.33%)
    4 / 40 (10.00%)
         occurrences all number
    1
    4
    Neuropathy peripheral
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 43 (27.91%)
    11 / 40 (27.50%)
         occurrences all number
    17
    12
    Oedema peripheral
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    Abdominal pain
         subjects affected / exposed
    23 / 43 (53.49%)
    15 / 40 (37.50%)
         occurrences all number
    36
    17
    Constipation
         subjects affected / exposed
    9 / 43 (20.93%)
    11 / 40 (27.50%)
         occurrences all number
    10
    13
    Diarrhoea
         subjects affected / exposed
    33 / 43 (76.74%)
    14 / 40 (35.00%)
         occurrences all number
    105
    22
    Dyspepsia
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    Flatulence
         subjects affected / exposed
    5 / 43 (11.63%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    Nausea
         subjects affected / exposed
    32 / 43 (74.42%)
    13 / 40 (32.50%)
         occurrences all number
    65
    21
    Rectal haemorrhage
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    Stomatitis
         subjects affected / exposed
    5 / 43 (11.63%)
    1 / 40 (2.50%)
         occurrences all number
    6
    1
    Vomiting
         subjects affected / exposed
    23 / 43 (53.49%)
    9 / 40 (22.50%)
         occurrences all number
    52
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 43 (13.95%)
    1 / 40 (2.50%)
         occurrences all number
    6
    1
    Dyspnoea
         subjects affected / exposed
    5 / 43 (11.63%)
    3 / 40 (7.50%)
         occurrences all number
    6
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 43 (0.00%)
    6 / 40 (15.00%)
         occurrences all number
    0
    6
    Alopecia
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 40 (10.00%)
         occurrences all number
    2
    5
    Rash
         subjects affected / exposed
    3 / 43 (6.98%)
    5 / 40 (12.50%)
         occurrences all number
    3
    6
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 40 (10.00%)
         occurrences all number
    2
    4
    Insomnia
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 43 (11.63%)
    6 / 40 (15.00%)
         occurrences all number
    7
    6
    Back pain
         subjects affected / exposed
    2 / 43 (4.65%)
    8 / 40 (20.00%)
         occurrences all number
    2
    8
    Muscle spasms
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 40 (10.00%)
         occurrences all number
    2
    6
    Pain in extremity
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 43 (13.95%)
    2 / 40 (5.00%)
         occurrences all number
    6
    2
    Infection
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 40 (2.50%)
         occurrences all number
    4
    2
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 43 (9.30%)
    3 / 40 (7.50%)
         occurrences all number
    4
    3
    Urinary tract infection
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    11 / 43 (25.58%)
    6 / 40 (15.00%)
         occurrences all number
    14
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2005
    Amendment no. 1, documented new preclinical (phototoxicity) data that had become available since the preparation of the original study protocol.
    04 Jan 2006
    Amendment no. 2, documented a rewording of inclusion criteria for clarification, following the suggestion of a study investigator, and the correction of a typographical error with regard to the description of the packages of study medication.
    26 Jan 2006
    Amendment no. 3, documented administrative changes and a clarification of the data collection procedures for patients who continued into the treatment extension period and the subsequent analyses of such data.

    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.
    From Nov2009-Mar2014,there was 1 patient who continued taking Nintedanib on compassionate use programme,but due to limited data collected for compassionate use patients,no further analyses/reanalyses were deemed necessary and no new AE data recorded
    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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