Clincosm LogoSign in Get a demo

An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01588184
Collaborator
(none)
95
Enrollment
73
Locations
6
Arms
86.5
Actual Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study
Actual Study Start Date :
Jul 13, 2012
Actual Primary Completion Date :
Sep 27, 2019
Actual Study Completion Date :
Sep 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breast Cancer

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Drug: Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Other Names:
  • Avastin

    		•
    Experimental: Ovarian Cancer or Peritoneal Carcinoma

    Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Drug: Bevacizumab
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
    Other Names:
  • Avastin

    		•
    Experimental: Renal Cell Carcinoma

    Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Drug: Bevacizumab
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
    Other Names:
  • Avastin

    		•
    Experimental: Colorectal Cancer

    Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Drug: Bevacizumab
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
    Other Names:
  • Avastin

    		•
    Experimental: Non-Squamous, Non-Small Cell Lung Cancer

    Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Drug: Bevacizumab
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
    Other Names:
  • Avastin

    		•
    Experimental: Glioblastoma Multiforme

    Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Drug: Bevacizumab
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
    Other Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Adverse Events [Baseline up to approximately 81 months]

      An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) [Baseline up to approximately 81 months]

      Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.

    2. Overall Survival (OS) [Baseline up to approximately 81 months]

      Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator

    • Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol

    • Able to comply with this extension study protocol (MO25757)

    Exclusion Criteria:

    • Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study

    • Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation

    • A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial

    • Evidence of any other disease that would put the participant at high risk for treatment-related complications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A.Ö. LKH; Abt. für Lungenkrankheiten Steyr Austria 4400
    2 Hospital Araujo Jorge; Departamento de Ginecologia E Mama Goiania GO Brazil 74605-070
    3 Hospital Sao Lucas - PUCRS Porto Alegre RS Brazil 90610-000
    4 Hospital de Cancer de Barretos Barretos SP Brazil 14784-400
    5 Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP Brazil 01246-000
    6 Hospital Perola Byington Sao Paulo SP Brazil 01317-000
    7 Hospital A. C. Camargo; Oncologia Sao Paulo SP Brazil 01509-010
    8 Hospital Sao Jose São Paulo SP Brazil CEP 01321-001
    9 MBAL Serdika EOOD Sofia Bulgaria 1632
    10 University Health Network; Princess Margaret Hospital; Medical Oncology Dept Toronto Ontario Canada M5G 2M9
    11 Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc Czechia 779 00
    12 North Estonia Medical Centre Foundation; Oncology Center Tallinn Estonia 13419
    13 HOPITAL JEAN MINJOZ; Oncologie Besancon France 25030
    14 Centre Leonard De Vinci;Chimiotherapie Dechy France 59187
    15 Centre Georges François Leclerc; Service Pharmacie, Bp 77980 Dijon France 21000
    16 Hopital Roger Salengro; Service de Neurologie Lille France
    17 Centre Leon Berard; Departement Oncologie Medicale Lyon France 69373
    18 Centre Paul Strauss; Oncologie Medicale Strasbourg France 67065
    19 Hopital Larrey; Pneumologie Toulouse France 31059
    20 Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie Frankfurt am Main Germany 60528
    21 LungenClinic Großhansdorf GmbH Großhansdorf Germany 22927
    22 Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly Budapest Hungary 1122
    23 A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica Napoli Campania Italy 80131
    24 Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Bologna Emilia-Romagna Italy 40138
    25 Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 Roma Lazio Italy 00152
    26 Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica Milano Lombardia Italy 20133
    27 Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica Milano Lombardia Italy 20141
    28 ASST DI MONZA; Oncologia Medica Monza Lombardia Italy 20900
    29 ASST LARIANA; Oncologia S. Fermo Della Battaglia (CO) Lombardia Italy 22020
    30 Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia Torino Piemonte Italy 10126
    31 Ospedale Antonio Perrino; Oncologia Medica Brindisi Puglia Italy 72100
    32 Centro Catanese Di Oncologia; Oncologia Medica Catania Sicilia Italy 95126
    33 Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica Lido Di Camaiore Toscana Italy 55043
    34 A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii Pisa Toscana Italy 56124
    35 Ospedale Misericordia E Dolce; Oncologia Medica Prato Toscana Italy 59100
    36 National Cancer Center; Medical Oncology Gyeonggi-do Korea, Republic of 410-769
    37 Severance Hospital; Internal Medicine Seoul Korea, Republic of 110-744
    38 Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology Seoul Korea, Republic of 138-736
    39 Instituto Nacional de Cancerologia; Oncology Distrito Federal Mexico 14080
    40 Fundación Rodolfo Padilla Padilla, A.C.; Oncology Leon Mexico 37000
    41 Oaxaca Site Management Organization Oaxaca Mexico 68000
    42 Leyenburg Hospital; Pulmonology Den Haag Netherlands 2504 LN
    43 Radboud Ziekenhuis; Urologie, 659 Nijmegen Netherlands 6525 GA
    44 Prof. Dr. I. Chiricuta Institute of Oncology Cluj Napoca Romania 400015
    45 Euroclinic Center of Oncology SRL Iasi Romania 700106
    46 Altai Region Oncology Dispensory; Oncology Barnaul Russian Federation 656049
    47 Regional Oncology Hospital; Oncology Irkutsk Russian Federation 664035
    48 Blokhin Cancer Research Center; Combined Treatment Moscow Russian Federation 115478
    49 Russian Research Center of Roentgenoradiology; Dept of Chemotherapy Moscow Russian Federation 117837
    50 P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept Moscow Russian Federation 125284
    51 City Clinical Oncology Hospital Moscow Russian Federation 143423
    52 Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease Obninsk, Kaluzhskaya Region Russian Federation 249034
    53 Bashkirian Republican Clinical Oncology Dispensary UFA Russian Federation 450054
    54 Vychodoslovensky onkologicky ustav Košice Slovakia 040 01
    55 Wits Donald Gordon Clinical Trial Centre; Medical Oncology Parktown, Johannesburg South Africa 2193
    56 Hospital de Basurto; Servicio de Oncologia Bilbao Vizcaya Spain 48013
    57 Hospital de Cruces; Servicio de Oncologia Bilbao Vizcaya Spain 48903
    58 Complejo Asistencial Universitario De Burgos; Servicio de Oncologia Burgos Spain 09006
    59 Hospital Reina Sofia; Medical Oncology Cordoba Spain 14004
    60 Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen Spain 23007
    61 Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología La Coruña Spain 15006
    62 Hospital Gregorio Marañon Madrid Spain 28007
    63 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
    64 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    65 Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Malaga Spain 29010
    66 Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia Valencia Spain 46010
    67 Mälarsjukhuset, Eskilstuna, Kvinnokliniken Eskilstuna Sweden 63188
    68 Norrlands universitetssjukhus; Onkologkliniken Umeå Sweden
    69 Universitetssjukhuset Örebro, Onkologiska kliniken Örebro Sweden 701 85
    70 Adana City Hospital, Medical Oncology Adana Turkey 01060
    71 Addenbrooke'S Hospital; Dept of Neurosurgery Cambridge United Kingdom CB2 2QQ
    72 Christie Hospital Nhs Trust; Medical Oncology Manchester United Kingdom M2O 4BX
    73 North Wales Cancer Treatment Centre, Glan Clwyd Hospital Rhyl United Kingdom LL18 5UJ

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01588184
    Other Study ID Numbers:
    • MO25757
    • 2011-002009-31
    First Posted:
    Apr 30, 2012
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Oct 1, 2020
    Additional relevant MeSH terms:
    Bevacizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The number of participants enrolled over the planned recruitment period was open. 95 participants actually enrolled in this study.
    Arm/Group Title Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Arm/Group Description Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Period Title: Overall Study
    STARTED 11 41 7 6 16 14
    COMPLETED 8 28 5 3 14 10
    NOT COMPLETED 3 13 2 3 2 4

    Baseline Characteristics

    Arm/Group Title Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme Total
    Arm/Group Description Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Total of all reporting groups
    Overall Participants 11 41 7 6 16 14 95
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.5
    (7.3)
    56.7
    (11.2)
    66.7
    (13.9)
    63.5
    (9.8)
    58.5
    (10.5)
    49.5
    (10.9)
    56.9
    (11.4)
    Sex: Female, Male (Count of Participants)
    Female
    11
    100%
    41
    100%
    3
    42.9%
    2
    33.3%
    6
    37.5%
    4
    28.6%
    67
    70.5%
    Male
    0
    0%
    0
    0%
    4
    57.1%
    4
    66.7%
    10
    62.5%
    10
    71.4%
    28
    29.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    11
    100%
    41
    100%
    7
    100%
    6
    100%
    16
    100%
    14
    100%
    95
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Adverse Events
    Description An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
    Time Frame Baseline up to approximately 81 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Arm/Group Description Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Measure Participants 11 41 7 6 16 14
    Number [percentage of participants]
    90.9
    826.4%
    78.0
    190.2%
    71.4
    1020%
    100.0
    1666.7%
    75.0
    468.8%
    83.2
    594.3%
    2. Secondary Outcome
    Title Progression Free Survival (PFS)
    Description Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.
    Time Frame Baseline up to approximately 81 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Arm/Group Description Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Measure Participants 11 41 7 6 16 14
    Mean (Standard Deviation) [months]
    35.31
    (23.809)
    24.39
    (19.759)
    17.98
    (24.202)
    9.31
    (12.046)
    17.14
    (14.152)
    11.31
    (10.301)
    3. Secondary Outcome
    Title Overall Survival (OS)
    Description Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.
    Time Frame Baseline up to approximately 81 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Arm/Group Description Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Measure Participants 11 41 7 6 16 14
    Mean (Standard Deviation) [months]
    38.82
    (24.159)
    27.35
    (20.020)
    20.30
    (23.761)
    11.98
    (10.950)
    18.31
    (14.962)
    12.99
    (10.795)

    Adverse Events

    Time Frame Baseline up to approximately 81 months
    Adverse Event Reporting Description
    Arm/Group Title Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Arm/Group Description Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    All Cause Mortality
    Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/11 (9.1%) 0/41 (0%) 0/7 (0%) 1/6 (16.7%) 1/16 (6.3%) 1/14 (7.1%)
    Serious Adverse Events
    Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/11 (18.2%) 2/41 (4.9%) 2/7 (28.6%) 3/6 (50%) 5/16 (31.3%) 3/14 (21.4%)
    Cardiac disorders
    CARDIAC FAILURE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    SINUS BRADYCARDIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Ear and labyrinth disorders
    VERTIGO 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Gastrointestinal disorders
    VOMITING 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Infections and infestations
    APPENDICITIS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    COMPLICATED APPENDICITIS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    INFECTION 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    MENINGITIS BACTERIAL 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    WOUND INFECTION 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Injury, poisoning and procedural complications
    FEMUR FRACTURE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    FRACTURE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    JAW FRACTURE 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Metabolism and nutrition disorders
    DEHYDRATION 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Nervous system disorders
    ISCHAEMIC STROKE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    TRANSIENT ISCHAEMIC ATTACK 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    Renal and urinary disorders
    NEPHROTIC SYNDROME 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    PNEUMONITIS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Vascular disorders
    AORTIC STENOSIS 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    CIRCULATORY COLLAPSE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    HYPERTENSIVE CRISIS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Other (Not Including Serious) Adverse Events
    Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/11 (90.9%) 31/41 (75.6%) 5/7 (71.4%) 6/6 (100%) 12/16 (75%) 14/14 (100%)
    Blood and lymphatic system disorders
    ANAEMIA 0/11 (0%) 0 5/41 (12.2%) 20 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    LEUKOPENIA 0/11 (0%) 0 2/41 (4.9%) 7 1/7 (14.3%) 3 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    NEUTROPENIA 0/11 (0%) 0 3/41 (7.3%) 9 1/7 (14.3%) 12 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    NEUTROPHILIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    THROMBOCYTOPENIA 0/11 (0%) 0 3/41 (7.3%) 10 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 2/14 (14.3%) 2
    Cardiac disorders
    BUNDLE BRANCH BLOCK RIGHT 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    CONGESTIVE CARDIOMYOPATHY 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Ear and labyrinth disorders
    EAR PAIN 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    VERTIGO 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Eye disorders
    CONJUNCTIVAL HAEMORRHAGE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    LACRIMATION INCREASED 1/11 (9.1%) 1 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    PERIORBITAL DISORDER 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    XEROPHTHALMIA 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Gastrointestinal disorders
    ABDOMINAL PAIN 1/11 (9.1%) 21 2/41 (4.9%) 2 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    ABDOMINAL PAIN UPPER 1/11 (9.1%) 1 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    CHEILITIS 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 3 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    CONSTIPATION 1/11 (9.1%) 1 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    DENTAL CARIES 0/11 (0%) 0 2/41 (4.9%) 2 1/7 (14.3%) 2 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    DIARRHOEA 2/11 (18.2%) 2 7/41 (17.1%) 19 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 2
    DYSPEPSIA 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    GASTRITIS EROSIVE 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    GINGIVAL BLEEDING 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 2/14 (14.3%) 2
    MOUTH ULCERATION 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    NAUSEA 2/11 (18.2%) 2 5/41 (12.2%) 8 0/7 (0%) 0 0/6 (0%) 0 3/16 (18.8%) 7 1/14 (7.1%) 1
    ORAL PAIN 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    PEPTIC ULCER 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    STOMATITIS 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    TOOTHACHE 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    VOMITING 2/11 (18.2%) 2 5/41 (12.2%) 5 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    General disorders
    ASTHENIA 4/11 (36.4%) 5 3/41 (7.3%) 5 0/7 (0%) 0 0/6 (0%) 0 3/16 (18.8%) 5 5/14 (35.7%) 6
    CHEST PAIN 1/11 (9.1%) 1 2/41 (4.9%) 3 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    FATIGUE 1/11 (9.1%) 1 4/41 (9.8%) 6 1/7 (14.3%) 1 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    MUCOSAL INFLAMMATION 0/11 (0%) 0 2/41 (4.9%) 2 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    OEDEMA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 1/14 (7.1%) 1
    OEDEMA PERIPHERAL 1/11 (9.1%) 1 4/41 (9.8%) 7 0/7 (0%) 0 0/6 (0%) 0 2/16 (12.5%) 3 0/14 (0%) 0
    PAIN 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    PYREXIA 0/11 (0%) 0 1/41 (2.4%) 2 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 2/14 (14.3%) 2
    Immune system disorders
    CONTRAST MEDIA ALLERGY 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    SEASONAL ALLERGY 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Infections and infestations
    BACTERIURIA 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    BREAST DISCHARGE INFECTED 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    BRONCHITIS 1/11 (9.1%) 1 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    CONJUNCTIVITIS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    CYSTITIS 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    DIVERTICULITIS 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    EAR INFECTION 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    INFLUENZA 1/11 (9.1%) 2 2/41 (4.9%) 2 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    LACRIMAL GLAND ABSCESS 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    NAIL INFECTION 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    NASOPHARYNGITIS 1/11 (9.1%) 3 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    PERIODONTITIS 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    RESPIRATORY TRACT INFECTION 0/11 (0%) 0 2/41 (4.9%) 2 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    RHINITIS 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    SINUSITIS 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    TOOTH ABSCESS 0/11 (0%) 0 3/41 (7.3%) 3 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    TOOTH INFECTION 1/11 (9.1%) 3 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    UPPER RESPIRATORY TRACT INFECTION 2/11 (18.2%) 2 2/41 (4.9%) 4 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    URINARY TRACT INFECTION 0/11 (0%) 0 9/41 (22%) 26 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION 1/11 (9.1%) 2 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Injury, poisoning and procedural complications
    ANKLE FRACTURE 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    FALL 0/11 (0%) 0 1/41 (2.4%) 3 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    INCISION SITE PAIN 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    RADIUS FRACTURE 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED 1/11 (9.1%) 3 2/41 (4.9%) 2 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 2
    AMYLASE INCREASED 1/11 (9.1%) 3 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    ASPARTATE AMINOTRANSFERASE INCREASED 2/11 (18.2%) 3 2/41 (4.9%) 3 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    BLOOD ALKALINE PHOSPHATASE INCREASED 1/11 (9.1%) 3 2/41 (4.9%) 9 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    BLOOD BILIRUBIN INCREASED 1/11 (9.1%) 1 0/41 (0%) 0 1/7 (14.3%) 2 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    BLOOD CREATININE INCREASED 0/11 (0%) 0 5/41 (12.2%) 10 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    BLOOD PRESSURE INCREASED 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 2/14 (14.3%) 3
    EJECTION FRACTION DECREASED 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED 2/11 (18.2%) 8 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    LIPASE INCREASED 1/11 (9.1%) 2 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    PLATELET COUNT DECREASED 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 2/14 (14.3%) 3
    WEIGHT DECREASED 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 2/16 (12.5%) 3 0/14 (0%) 0
    WEIGHT INCREASED 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    Metabolism and nutrition disorders
    DECREASED APPETITE 0/11 (0%) 0 3/41 (7.3%) 4 0/7 (0%) 0 0/6 (0%) 0 2/16 (12.5%) 2 1/14 (7.1%) 1
    GOUT 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    HYPERGLYCAEMIA 0/11 (0%) 0 3/41 (7.3%) 15 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    HYPOALBUMINAEMIA 1/11 (9.1%) 1 4/41 (9.8%) 11 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    HYPOCALCAEMIA 1/11 (9.1%) 1 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    HYPOKALAEMIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    HYPONATRAEMIA 2/11 (18.2%) 2 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    IRON DEFICIENCY 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 2/11 (18.2%) 2 1/41 (2.4%) 1 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 2/14 (14.3%) 2
    BACK PAIN 1/11 (9.1%) 1 5/41 (12.2%) 5 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    MUSCLE SPASMS 2/11 (18.2%) 6 1/41 (2.4%) 2 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    MUSCULOSKELETAL DISCOMFORT 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    MUSCULOSKELETAL PAIN 4/11 (36.4%) 7 2/41 (4.9%) 2 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 2 0/14 (0%) 0
    MYALGIA 1/11 (9.1%) 1 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    NECK PAIN 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 2
    OSTEOARTHRITIS 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    PAIN IN EXTREMITY 1/11 (9.1%) 1 1/41 (2.4%) 3 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    PERIARTHRITIS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    SPINAL PAIN 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 2 0/14 (0%) 0
    Nervous system disorders
    APHONIA 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    COMPLEX REGIONAL PAIN SYNDROME 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    DIZZINESS 0/11 (0%) 0 3/41 (7.3%) 3 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    DYSAESTHESIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    DYSTONIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    FACIAL NEURALGIA 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    HEADACHE 3/11 (27.3%) 5 4/41 (9.8%) 6 1/7 (14.3%) 1 0/6 (0%) 0 1/16 (6.3%) 1 6/14 (42.9%) 7
    HYPOAESTHESIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 2 0/14 (0%) 0
    MIGRAINE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    MOVEMENT DISORDER 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    NERVOUS SYSTEM DISORDER 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    NEUROPATHY PERIPHERAL 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    NEUROTOXICITY 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    PARAESTHESIA 0/11 (0%) 0 2/41 (4.9%) 2 0/7 (0%) 0 0/6 (0%) 0 2/16 (12.5%) 2 0/14 (0%) 0
    PERIPHERAL SENSORY NEUROPATHY 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    SCIATICA 1/11 (9.1%) 2 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    SEIZURE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    SOMNOLENCE 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Psychiatric disorders
    IRRITABILITY 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Renal and urinary disorders
    PROTEINURIA 6/11 (54.5%) 55 20/41 (48.8%) 100 2/7 (28.6%) 5 1/6 (16.7%) 1 8/16 (50%) 26 5/14 (35.7%) 15
    RENAL FAILURE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    RENAL IMPAIRMENT 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    URINARY INCONTINENCE 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Reproductive system and breast disorders
    CYSTOCELE 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    ERECTILE DYSFUNCTION 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    UTERINE PROLAPSE 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    COUGH 4/11 (36.4%) 5 1/41 (2.4%) 2 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 1/14 (7.1%) 1
    DYSPHONIA 1/11 (9.1%) 1 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    DYSPNOEA 2/11 (18.2%) 4 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    EPISTAXIS 1/11 (9.1%) 1 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 2/16 (12.5%) 3 2/14 (14.3%) 3
    OROPHARYNGEAL PAIN 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/14 (0%) 0
    PRODUCTIVE COUGH 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    RHINORRHOEA 2/11 (18.2%) 2 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Skin and subcutaneous tissue disorders
    ALOPECIA 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    ERYTHEMA 0/11 (0%) 0 0/41 (0%) 0 1/7 (14.3%) 1 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    ONYCHOLYSIS 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME 1/11 (9.1%) 1 0/41 (0%) 0 1/7 (14.3%) 4 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    RASH 0/11 (0%) 0 1/41 (2.4%) 1 0/7 (0%) 0 0/6 (0%) 0 2/16 (12.5%) 3 0/14 (0%) 0
    RASH MACULAR 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    SKIN SWELLING 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Surgical and medical procedures
    TOOTH EXTRACTION 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Vascular disorders
    EMBOLISM VENOUS 0/11 (0%) 0 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    HYPERTENSION 2/11 (18.2%) 3 7/41 (17.1%) 25 0/7 (0%) 0 2/6 (33.3%) 5 1/16 (6.3%) 1 0/14 (0%) 0
    LYMPHOEDEMA 1/11 (9.1%) 1 0/41 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/14 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800 821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01588184
    Other Study ID Numbers:
    • MO25757
    • 2011-002009-31
    First Posted:
    Apr 30, 2012
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Oct 1, 2020