OPALINE : A Study Of Morbidity And Mortality At 2 Years | NCT02264665 | Trialant
NCT02264665
Sponsor
Pfizer
Status
Completed
Last Update Posted
Nov 13, 2023Actual
Enrollment
144Actual
Phase
Not provided
Conditions
Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Interventions
sunitinib
everolimus
chemotherapies recommended in france
Countries
France
Protocol Section
Identification Module
NCT ID
NCT02264665
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A6181214
Secondary IDs
ID
Type
Description
Link
OPALINE
Other Identifier
Alias Study Number
Brief Title
OPALINE : A Study Of Morbidity And Mortality At 2 Years
Official Title
AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS
Acronym
OPALINE
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 2023
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
May 12, 2015Actual
Primary Completion Date
Nov 18, 2019Actual
Completion Date
Nov 18, 2019Actual
First Submitted Date
Sep 2, 2014
First Submission Date that Met QC Criteria
Oct 9, 2014
First Posted Date
Oct 15, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 14, 2022
Results First Submitted that Met QC Criteria
Nov 9, 2023
Results First Posted Date
Nov 13, 2023Actual
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
Nov 9, 2023
Last Update Posted Date
Nov 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Novartis
INDUSTRY
Keyrus Biopharma
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.
Detailed Description
prospective and retrospective Analyses will be performed using SAS® software
Conditions Module
Conditions
Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion
PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
At 2 years of prospective follow-up
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
At 2 years of prospective follow-up
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion
OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
Secondary Outcomes
Measure
Description
Time Frame
Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
During 2 years of prospective follow-up
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age;
Patients treated with a targeted therapy (sunitinib, everolimus) or with other treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin analog)* for:
*Patients whose treatment line (targeted therapy or other treatment) is initiated as a 1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment was initiated in the site in which the patient is enrolled in the study (prevalent patients); a change of line is defined as a change in molecule or combination.
A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor;
Well-differentiated;
Progressive prior to initiation of treatment in the investigator's judgment (clinical or radiological progression);
Patients who have been informed of the conditions of the study and who have signed the informed consent.
Exclusion Criteria:
Patients with a diagnosis of poorly differentiated neuroendocrine carcinoma or an adenoneuroendocrine carcinoma.
Patients receiving targeted therapy (everolimus or sunitinib) already received in a previous line of treatment (rechallenged patient).
Patients refusing to give consent.
Patients receiving a fifth line or subsequent line of systemic treatment.
Patients participating in a clinical trial in a treatment arm not validated by the MA and the TNCD according to the version dated December 2013.
Patients randomized to the placebo arm of a placebo-controlled trial or to a double-blind trial.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Patients with progressive, metastatic or unresectable, and well differentiated pancreatic neuroendocrine tumors
Smith D, Lepage C, Vicaut E, Dominguez S, Coriat R, Dubreuil O, Lecomte T, Baudin E, Venat Bouvet L, Samalin E, Santos A, Borie O, Bisot-Locard S, Goichot B, Lombard-Bohas C. Observational Study in a Real-World Setting of Targeted Therapy in the Systemic Treatment of Progressive Unresectable or Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors (pNETs) in France: OPALINE Study. Adv Ther. 2022 Jun;39(6):2731-2748. doi: 10.1007/s12325-022-02103-7. Epub 2022 Apr 13.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
This was an observational study carried out in France in adult participants treated for a well-differentiated, unresectable or metastatic, progressive pancreatic neuroendocrine tumor (pNET).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Everolimus (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.
OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion
OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
At 2 years of prospective follow-up
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion
During 2 years of prospective follow-up
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study
AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
During 2 years of prospective follow-up
Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
During 2 years of prospective follow-up
Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
During 2 years of prospective follow-up
Frequency = number of tumor assessment visits /([last visit date - baseline date]/365.25).
During 2 years of prospective follow-up
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The different types of investigations were performed for assessment of tumor regardless of treatment received. Investigations performed were Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scan, Octreoscan, Ultrasound. All the investigations were used at least once during the study for all treatments.
During 2 years of prospective follow-up
Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
In this outcome measure, number of participants with a change in treatment compared to treatment at inclusion is reported.
During 2 years of prospective follow-up
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion
Number of participants according to number of changes in doses of treatment is reported for this outcome measure.
During 2 years of prospective follow-up
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion
Number of participants according to course of changes in doses of treatment is reported for this outcome measure.
During 2 years of prospective follow-up
Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The number of lines of combined main treatment administered during the study were assessed.
During 2 years of prospective follow-up
Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The number of main lines of treatment received during the study treatment are reported in this outcome measure.
During 2 years of prospective follow-up
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The types of main lines of treatment included 1st line, 2nd line, 3rd line, 4th line, 5th line, 6th line, 7th line and 8th line.
During 2 years of prospective follow-up
Angers
49100
France
Hopital Saint-Andre
Bordeaux
33000
France
CHU de Caen
Caen
14000
France
Cabinet Medical
Challes-les-Eaux
73190
France
CHRU de Tours - Hôpital TROUSSEAU
Chambray-lès-Tours
37170
France
Hopital d'Estaing
Clermont-Ferrand
63003
France
Hopital du Bocage
Dijon
21079
France
Unite d'Oncologie Digestive, Departement d'HGE
Grenoble
38043
France
Centre Oscar Lambret
Lille
59020
France
Chu Dupuytren Service Oncologie
Limoges
87000
France
CH Bretagne Sud
Lorient
56100
France
Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive
Lyon
69437
France
Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H
Lyon
69437
France
Hopital Edouard Herriot, Pavillion O, Oncologie Medicale
Lyon
69437
France
Hopital La Timone Service de Gastroenterologie et Oncologie Digestive
Hopital Robert Debre, Service D'Hepato-gastro-enterolo
Reims
51092
France
Clinique Armoricaine
Saint-Brieuc
France
Pôle Hospitalier Mutualiste
Saint-Nazaire
44600
France
Clinique Mutualiste de l'estuaire
Saint-Nazaire
44606
France
CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition
Strasbourg
67098
France
Hopital Foch, Onco Hermatologie
Suresnes
92151
France
Cabinet Medical
Vannes
56000
France
Institut Gustave Roussy
Villejuif
94805
France
Sunitinib (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.
FG002
Chemotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.
FG003
Somatostatin Analogues (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.
FG004
Metabolic Radiotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.
FG005
Interferon-alpha (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with interferon-alpha or were being treated with interferon-alpha. Participants were prospectively followed-up for 2 years in this study.
FG006
Treatment Not Documented
This reporting group consisted of those participants whose treatment was not documented at time of inclusion.
FG00035 subjects
FG00123 subjects
FG00252 subjects
FG00330 subjects
FG0041 subjects
FG0050 subjects
FG0063 subjects
Reference Set (Full Analysis Set)
FG00032 subjects
FG00123 subjects
FG00250 subjects
FG00328 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Safety Set
FG00035 subjects
FG00123 subjects
FG00252 subjects
FG00330 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00022 subjects
FG00115 subjects
FG00231 subjects
FG00321 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00013 subjects
FG0018 subjects
FG00221 subjects
FG0039 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0009 subjects
FG0018 subjects
FG00213 subjects
FG0035 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Participant decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Inclusion/non-inclusion criteria not respected
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
Data Missing
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
The full analysis (FAS) (reference) set included participants who met the eligibility criteria and had received at least 1 dose of the treatment documented during the prospective follow-up period (the treatment start date must be completed and the treatment stop date must be after the date of inclusion if the start date is prior to the date of inclusion) in the study (targeted therapy or other treatment) and excluded the participants with no follow-up data.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Everolimus (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.
BG001
Sunitinib (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.
BG002
Chemotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.
BG003
Somatostatin Analogues (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.
BG004
Metabolic Radiotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00123
BG00250
BG00328
BG0041
BG005134
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
ParticipantsBG00032
ParticipantsBG00123
ParticipantsBG00250
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00032
ParticipantsBG00123
ParticipantsBG002
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
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
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion
PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At 2 years of prospective follow-up
ID
Title
Description
OG000
Everolimus (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.
OG001
Sunitinib (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.
OG002
Chemotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.
OG003
Somatostatin Analogues (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.
OG004
Metabolic Radiotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.
Units
Counts
Participants
OG00032
OG00123
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
OG00026.5(10.3 to 46.0)
OG00119.3(4.6 to 41.4)
OG00236.5(13.8 to 60.0)
OG003
Primary
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
Primary
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion
OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, "Overall Number of Participants" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At 2 years of prospective follow-up
ID
Title
Description
OG000
Everolimus (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.
OG001
Sunitinib (Targeted Therapy) at Inclusion
Primary
OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion
OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, "Overall Number of Participants" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Primary
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion
Safety analysis set included participants who received at least one dose of the documented treatment in the study (targeted therapy or other treatment). If the participant was prevalent, the treatment must still be ongoing at the time of inclusion in the study and if the participant was incident, the treatment must be started at or after inclusion in the study. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study
AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Everolimus During Study
Participants who received everolimus at least once in the study.
Primary
Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Everolimus During Study
Participants who received everolimus at least once in the study.
OG001
Sunitinib During Study
Participants who received sunitinib at least once in the study.
OG002
Chemotherapy During Study
Participants who received chemotherapy at least once in the study.
Primary
Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Everolimus During Study
Participants who received everolimus at least once in the study.
OG001
Sunitinib During Study
Participants who received sunitinib at least once in the study.
OG002
Chemotherapy During Study
Participants who received chemotherapy at least once in the study.
Secondary
Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Mean
Standard Deviation
Visits
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Units
Counts
Secondary
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
Frequency = number of tumor assessment visits /([last visit date - baseline date]/365.25).
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Secondary
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The different types of investigations were performed for assessment of tumor regardless of treatment received. Investigations performed were Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scan, Octreoscan, Ultrasound. All the investigations were used at least once during the study for all treatments.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Secondary
Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
In this outcome measure, number of participants with a change in treatment compared to treatment at inclusion is reported.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Secondary
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion
Number of participants according to number of changes in doses of treatment is reported for this outcome measure.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Everolimus (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.
OG001
Sunitinib (Targeted Therapy) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.
Secondary
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion
Number of participants according to course of changes in doses of treatment is reported for this outcome measure.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Metabolic Radiotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.
Units
Counts
Participants
OG000
Secondary
Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The number of lines of combined main treatment administered during the study were assessed.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Mean
Standard Deviation
Treatment lines
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Secondary
Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The number of main lines of treatment received during the study treatment are reported in this outcome measure.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Mean
Standard Deviation
Treatment lines
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Secondary
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The types of main lines of treatment included 1st line, 2nd line, 3rd line, 4th line, 5th line, 6th line, 7th line and 8th line.
FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
Posted
Count of Participants
Participants
During 2 years of prospective follow-up
ID
Title
Description
OG000
Targeted Therapy at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Time Frame
During 2 years of prospective follow-up
Description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
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
Everolimus During Study
Participants who received everolimus at least once in the study.
4
52
21
52
39
52
EG001
Sunitinib During Study
Participants who received sunitinib at least once in the study.
3
36
9
36
29
36
EG002
Chemotherapy During Study
Participants who received chemotherapy at least once in the study.
15
82
26
82
56
82
EG003
Somatostatin Analogues During Study
Participants who received somatostatin analogues at least once in the study.
14
65
24
65
41
65
EG004
Metabolic Radiotherapy During Study
Participants who received metabolic radiotherapy at least once in the study.
2
11
3
11
4
11
EG005
Other Than Study Treatment During Study
Participants who received treatment other than the study treatments at least once in the study.
1
16
3
16
8
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Disease progression
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected52 at risk
EG0012 affected36 at risk
EG0025 affected82 at risk
EG0038 affected65 at risk
EG0040 affected11 at risk
EG0051 affected16 at risk
General physical health deterioration
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0010 affected36 at risk
EG0024 affected82 at risk
EG003
Condition aggravated
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Death
General disorders
MedDRA v22.0
Non-systematic Assessment
Reasons for death were unknown for both the participants.
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Oedema
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Mesenteric vein thrombosis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Endocarditis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Enterobacter sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Erysipelas
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Implant site infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Peritonitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Prostatitis Escherichia coli
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0012 affected36 at risk
EG0020 affected82 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Chemical peritonitis
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Complex regional pain syndrome
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Device occlusion
Product Issues
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asthenia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected52 at risk
EG0016 affected36 at risk
EG00224 affected82 at risk
EG0038 affected65 at risk
EG0041 affected11 at risk
EG0052 affected16 at risk
Mucosal inflammation
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0008 affected52 at risk
EG0013 affected36 at risk
EG0022 affected82 at risk
EG003
Oedema peripheral
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected52 at risk
EG0011 affected36 at risk
EG0023 affected82 at risk
EG003
Pyrexia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0012 affected36 at risk
EG0024 affected82 at risk
EG003
General physical health deterioration
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Fatigue
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Oedema
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Chest discomfort
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Device related thrombosis
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Disease progression
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Drug intolerance
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Face oedema
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Gait disturbance
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hernia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Impaired healing
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Injection site swelling
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Xerosis
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected52 at risk
EG0019 affected36 at risk
EG00212 affected82 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0010 affected36 at risk
EG00214 affected82 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected52 at risk
EG0014 affected36 at risk
EG0027 affected82 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0025 affected82 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0006 affected52 at risk
EG0012 affected36 at risk
EG0020 affected82 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0014 affected36 at risk
EG0023 affected82 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0013 affected36 at risk
EG0023 affected82 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0024 affected82 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0012 affected36 at risk
EG0020 affected82 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Gastrointestinal hypermotility
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Oedema mouth
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0015 affected36 at risk
EG0023 affected82 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0029 affected82 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0026 affected82 at risk
EG003
Headache
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0023 affected82 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Amnesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Parosmia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Psychomotor skills impaired
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0018 affected36 at risk
EG0027 affected82 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected52 at risk
EG0013 affected36 at risk
EG00210 affected82 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0012 affected36 at risk
EG0023 affected82 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Hyperleukocytosis
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Macrocytosis
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0023 affected82 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Abscess neck
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Ear infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Erysipelas
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Influenza
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Lung infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Sepsis
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0011 affected36 at risk
EG0023 affected82 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0022 affected82 at risk
EG003
Amyotrophy
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0012 affected36 at risk
EG0026 affected82 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Cell death
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0014 affected36 at risk
EG0021 affected82 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0022 affected82 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0013 affected36 at risk
EG0020 affected82 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hair disorder
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Plantar erythema
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Weight decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0004 affected52 at risk
EG0012 affected36 at risk
EG0022 affected82 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0013 affected36 at risk
EG0022 affected82 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Blood calcium abnormal
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Blood sodium abnormal
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Gammaglutamyltransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Liver function test abnormal
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Prothrombin time ratio decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Transaminases increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0012 affected36 at risk
EG0020 affected82 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0012 affected36 at risk
EG0020 affected82 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0022 affected82 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Pericardial disease
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Persistent corneal epithelial defect
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hot flush
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0022 affected82 at risk
EG003
Hypertension
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Phlebitis
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Thrombosis
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0021 affected82 at risk
EG003
Cholangitis chronic
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Cholangitis sclerosing
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Ear neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0001 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0011 affected36 at risk
EG0020 affected82 at risk
EG003
Diabetes insipidus
Endocrine disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0020 affected82 at risk
EG003
Liver transplant
Surgical and medical procedures
MedDRA v22.0
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected36 at risk
EG0021 affected82 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
OG004NA(NA to NA)Survival analysis not performed with only one participant at risk.
OG001
Other Treatments at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Units
Counts
Participants
OG00055
OG00178
Title
Denominators
Categories
Title
Measurements
OG00019.9(9.2 to 33.4)
OG00129.0(14.7 to 45.0)
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.
OG002
Chemotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.
OG003
Somatostatin Analogues (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.
OG004
Metabolic Radiotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.
Units
Counts
Participants
OG00032
OG00123
OG00250
OG00328
OG0041
Title
Denominators
Categories
Title
Measurements
OG00060.2(37.6 to 76.8)
OG00168.4(37.8 to 86.2)
OG00269.6(52.6 to 81.6)
OG00379.7(48.0 to 93.2)
OG004NA(NA to NA)Survival analysis not performed with only one participant at risk.
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.
Units
Counts
Participants
OG00055
OG00179
Title
Denominators
Categories
Title
Measurements
OG00063.9(46.8 to 76.8)
OG00171.7(57.2 to 82.1)
Units
Counts
Participants
OG00020
OG00122
Title
Denominators
Categories
Title
Measurements
Adverse event
OG00012
OG0016
Doctor's choice
OG0001
OG00111
Participant's choice
OG0003
OG0013
Other
OG0004
OG0012
OG001
Sunitinib During Study
Participants who received sunitinib at least once in the study.
OG002
Chemotherapy During Study
Participants who received chemotherapy at least once in the study.
OG003
Somatostatin Analogues During Study
Participants who received somatostatin analogues at least once in the study.
OG004
Metabolic Radiotherapy During Study
Participants who received metabolic radiotherapy at least once in the study.
OG005
Other Than Study Treatments During Study
Participants who received treatment other than the study treatments at least once in the study.
Units
Counts
Participants
OG00052
OG00136
OG00282
OG00365
OG00411
OG00516
Title
Denominators
Categories
AE
Title
Measurements
OG00043
OG00132
OG00263
OG00348
OG0046
OG0058
Treatment Related AE
Title
Measurements
OG00031
OG00124
OG00248
OG003
SAE
Title
Measurements
OG00021
OG0019
OG00226
OG003
Treatment Related SAE
Title
Measurements
OG0006
OG0012
OG0025
OG003
At least one grade 3 AE
Title
Measurements
OG00021
OG00111
OG00218
OG003
At least one grade 3 SAE
Title
Measurements
OG00014
OG0016
OG00212
OG003
At least one AE of grade 4 or higher
Title
Measurements
OG0006
OG0012
OG00218
OG003
OG003
Somatostatin Analogues During Study at Inclusion
Participants who received somatostatin analogues at least once in the study.
OG004
Metabolic Radiotherapy During Study
Participants who received metabolic radiotherapy at least once in the study
OG005
Other Than Study Treatment During Study
Participants who received treatment other than the study treatments at least once in the study.
Units
Counts
Participants
OG00052
OG00136
OG00282
OG00365
OG00411
OG00516
Title
Denominators
Categories
Temporary discontinuation of treatment
Title
Measurements
OG00015
OG0019
OG00211
OG0038
OG0040
OG0051
Permanent discontinuation of treatment
Title
Measurements
OG00014
OG00110
OG00212
OG003
OG003
Somatostatin Analogues During Study at Inclusion
Participants who received somatostatin analogues at least once in the study.
OG004
Metabolic Radiotherapy During Study
Participants who received metabolic radiotherapy at least once in the study
OG005
Other Than Study Treatments During Study
Participants who received treatment other than the study treatments at least once in the study.
Units
Counts
Participants
OG00052
OG00136
OG00282
OG00365
OG00411
OG00516
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG00211
OG00312
OG0042
OG0051
Participants
OG00055
OG00179
Title
Denominators
Categories
Title
Measurements
OG0005.8± 2.7
OG0015.5± 2.7
Units
Counts
Participants
OG00055
OG00179
Title
Denominators
Categories
Title
Measurements
0 tests per annum
OG0002
OG0013
2 tests per annum
OG0003
OG0014
3 tests per annum
OG00019
OG00126
4 tests per annum
OG00018
OG00130
5 tests per annum
OG00010
OG00110
6 tests per annum
OG0002
OG0014
7 tests per annum
OG0001
OG0010
9 tests per annum
OG0000
OG0012
Units
Counts
Participants
OG00053
OG00176
Title
Denominators
Categories
CT Scan
Title
Measurements
OG00048
OG00165
MRI
Title
Measurements
OG00028
OG00145
PET Scan
Title
Measurements
OG00011
OG00115
Octreoscan
Title
Measurements
OG00013
OG00115
Ultrasound
Title
Measurements
OG0006
OG0014
Imaging (CT scan and/or MRI)
Title
Measurements
OG00052
OG00174
Units
Counts
Participants
OG00055
OG00179
Title
Denominators
Categories
Title
Measurements
OG00044
OG00168
OG002
Chemotherapy (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.
OG003
Somatostatin Analogues (Other Treatment) at Inclusion
Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.