An Extension Study to Provide Continued Bevacizumab Thera... | NCT01588184 | Trialant
NCT01588184
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Nov 5, 2020Actual
Enrollment
95Actual
Phase
Phase 4
Conditions
Neoplasms
Interventions
Bevacizumab
Countries
Austria
Brazil
Bulgaria
Canada
Czechia
Estonia
France
Germany
Hungary
Italy
Mexico
Netherlands
Romania
Russia
Slovakia
South Africa
South Korea
Spain
Sweden
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01588184
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MO25757
Secondary IDs
ID
Type
Description
Link
2011-002009-31
EudraCT Number
Brief Title
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
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
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Oct 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 13, 2012Actual
Primary Completion Date
Sep 27, 2019Actual
Completion Date
Sep 27, 2019Actual
First Submitted Date
Apr 26, 2012
First Submission Date that Met QC Criteria
Apr 26, 2012
First Posted Date
Apr 30, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 11, 2020
Results First Submitted that Met QC Criteria
Oct 15, 2020
Results First Posted Date
Nov 5, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 15, 2020
Last Update Posted Date
Nov 5, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Breast Cancer
Experimental
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Drug: Bevacizumab
Ovarian Cancer or Peritoneal Carcinoma
Experimental
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Drug: Bevacizumab
Renal Cell Carcinoma
Experimental
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Drug: Bevacizumab
Colorectal Cancer
Experimental
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Drug: Bevacizumab
Non-Squamous, Non-Small Cell Lung Cancer
Experimental
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bevacizumab
Drug
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).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Adverse Events
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.
Baseline up to approximately 81 months
Secondary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS)
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.
Baseline up to approximately 81 months
Overall Survival (OS)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
A.Ö. LKH; Abt. für Lungenkrankheiten
Steyr
4400
Austria
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Oza AM, Dubois F, Hegg R, Hernandez CA, Finocchiaro G, Ghiringhelli F, Zamagni C, Nick S, Irahara N, Perretti T, Colombo N. A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors. Oncologist. 2021 Dec;26(12):e2254-e2264. doi: 10.1002/onco.13971. Epub 2021 Oct 4.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The number of participants enrolled over the planned recruitment period was open. 95 participants actually enrolled in this study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
FG001
Ovarian Cancer or Peritoneal Carcinoma
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 8, 2018
Sep 11, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Bevacizumab
Glioblastoma Multiforme
Experimental
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Drug: Bevacizumab
Breast Cancer
Colorectal Cancer
Glioblastoma Multiforme
Non-Squamous, Non-Small Cell Lung Cancer
Ovarian Cancer or Peritoneal Carcinoma
Renal Cell Carcinoma
Avastin
Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.
Baseline up to approximately 81 months
Goiânia
Goiás
74605-070
Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre
Rio Grande do Sul
90610-000
Brazil
Hospital de Cancer de Barretos
Barretos
São Paulo
14784-400
Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo
São Paulo
01246-000
Brazil
Hospital Perola Byington
São Paulo
São Paulo
01317-000
Brazil
Hospital A. C. Camargo; Oncologia
São Paulo
São Paulo
01509-010
Brazil
Hospital Sao Jose
São Paulo
São Paulo
CEP 01321-001
Brazil
MBAL Serdika EOOD
Sofia
1632
Bulgaria
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto
Ontario
M5G 2M9
Canada
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc
779 00
Czechia
North Estonia Medical Centre Foundation; Oncology Center
Tallinn
13419
Estonia
HOPITAL JEAN MINJOZ; Oncologie
Besançon
25030
France
Centre Leonard De Vinci;Chimiotherapie
Dechy
59187
France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon
21000
France
Hopital Roger Salengro; Service de Neurologie
Lille
France
Centre Leon Berard; Departement Oncologie Medicale
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl
LL18 5UJ
United Kingdom
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
FG002
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
FG003
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
FG004
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.
FG005
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
FG00011 subjects
FG00141 subjects
FG0027 subjects
FG0036 subjects
FG00416 subjects
FG00514 subjects
COMPLETED
FG0008 subjects
FG00128 subjects
FG0025 subjects
FG0033 subjects
FG00414 subjects
FG00510 subjects
NOT COMPLETED
FG0003 subjects
FG00113 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0054 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG004
Bevacizumab treatment provision changed
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG0030 subjects
FG004
multiple reasons
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
BG001
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
BG002
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
BG003
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
BG004
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.
BG005
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00141
BG0027
BG0036
BG00416
BG00514
BG00695
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.5± 7.3
BG00156.7± 11.2
BG00266.7± 13.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00141
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Adverse Events
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.
Posted
Number
percentage of participants
Baseline up to approximately 81 months
ID
Title
Description
OG000
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG001
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG002
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG003
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG004
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.
OG005
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Units
Counts
Participants
OG00011
OG00141
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG00090.9
OG00178.0
OG00271.4
OG003
Secondary
Progression Free Survival (PFS)
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.
Posted
Mean
Standard Deviation
months
Baseline up to approximately 81 months
ID
Title
Description
OG000
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG001
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG002
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG003
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Secondary
Overall Survival (OS)
Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.
Posted
Mean
Standard Deviation
months
Baseline up to approximately 81 months
ID
Title
Description
OG000
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG001
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG002
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
OG003
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Time Frame
Baseline up to approximately 81 months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
1
11
2
11
10
11
EG001
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
0
41
2
41
31
41
EG002
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
0
7
2
7
5
7
EG003
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
1
6
3
6
6
6
EG004
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.
1
16
5
16
12
16
EG005
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
1
14
3
14
14
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CARDIAC FAILURE
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected16 at risk
EG0050 events0 affected14 at risk
SINUS BRADYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
COMPLICATED APPENDICITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
MENINGITIS BACTERIAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
WOUND INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
JAW FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ISCHAEMIC STROKE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NEPHROTIC SYNDROME
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
AORTIC STENOSIS
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CIRCULATORY COLLAPSE
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPERTENSIVE CRISIS
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG00120 events5 affected41 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected16 at risk
EG0051 events1 affected14 at risk
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0017 events2 affected41 at risk
EG0023 events1 affected7 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0019 events3 affected41 at risk
EG00212 events1 affected7 at risk
EG003
NEUTROPHILIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG00110 events3 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BUNDLE BRANCH BLOCK RIGHT
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CONGESTIVE CARDIOMYOPATHY
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CONJUNCTIVAL HAEMORRHAGE
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
PERIORBITAL DISORDER
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
XEROPHTHALMIA
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG00021 events1 affected11 at risk
EG0012 events2 affected41 at risk
EG0021 events1 affected7 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CHEILITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0023 events1 affected7 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected41 at risk
EG0022 events1 affected7 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG00119 events7 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0018 events5 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
PEPTIC ULCER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0022 events1 affected7 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0022 events1 affected7 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0015 events5 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ASTHENIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0005 events4 affected11 at risk
EG0015 events3 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CHEST PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0013 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
FATIGUE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0016 events4 affected41 at risk
EG0021 events1 affected7 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
OEDEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0017 events4 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
PYREXIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CONTRAST MEDIA ALLERGY
Immune system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BACTERIURIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BREAST DISCHARGE INFECTED
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
LACRIMAL GLAND ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NAIL INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0003 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
RHINITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected7 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0003 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0014 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG00126 events9 affected41 at risk
EG0020 events0 affected7 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
INCISION SITE PAIN
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
RADIUS FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0003 events1 affected11 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
AMYLASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0003 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0003 events2 affected11 at risk
EG0013 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0003 events1 affected11 at risk
EG0019 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0022 events1 affected7 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG00110 events5 affected41 at risk
EG0020 events0 affected7 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0008 events2 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0014 events3 affected41 at risk
EG0020 events0 affected7 at risk
EG003
GOUT
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG00115 events3 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG00111 events4 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
IRON DEFICIENCY
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected7 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0015 events5 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0006 events2 affected11 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MUSCULOSKELETAL DISCOMFORT
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0007 events4 affected11 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0013 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PERIARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
APHONIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
COMPLEX REGIONAL PAIN SYNDROME
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DYSAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DYSTONIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
FACIAL NEURALGIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0005 events3 affected11 at risk
EG0016 events4 affected41 at risk
EG0021 events1 affected7 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
MOVEMENT DISORDER
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NERVOUS SYSTEM DISORDER
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
NEUROTOXICITY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG00055 events6 affected11 at risk
EG001100 events20 affected41 at risk
EG0025 events2 affected7 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
CYSTOCELE
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
ERECTILE DYSFUNCTION
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
UTERINE PROLAPSE
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0005 events4 affected11 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events2 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected7 at risk
EG003
ONYCHOLYSIS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0024 events1 affected7 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected7 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
SKIN SWELLING
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
TOOTH EXTRACTION
Surgical and medical procedures
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
EMBOLISM VENOUS
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events2 affected11 at risk
EG00125 events7 affected41 at risk
EG0020 events0 affected7 at risk
EG003
LYMPHOEDEMA
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.