To Compare The Effects Of Two Doses Of Vandetanib In Pati... | NCT01496313 | Trialant
NCT01496313
Sponsor
Sanofi
Status
Completed
Last Update Posted
Oct 3, 2025Actual
Enrollment
81Actual
Phase
Phase 4
Conditions
Thyroid Cancer
Interventions
300mg vandetanib
150mg vandetanib
Countries
United States
Czechia
India
Israel
Italy
Netherlands
Poland
Russia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01496313
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4200C00097
Secondary IDs
ID
Type
Description
Link
LPS14809
Other Identifier
Sanofi Identifier
2011-004701-24
EudraCT Number
Brief Title
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Official Title
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Sep 2025
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
Jun 8, 2012Actual
Primary Completion Date
Apr 2, 2014Actual
Completion Date
Jul 11, 2024Actual
First Submitted Date
Dec 2, 2011
First Submission Date that Met QC Criteria
Dec 19, 2011
First Posted Date
Dec 21, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 1, 2015
Results First Submitted that Met QC Criteria
Oct 27, 2015
Results First Posted Date
Nov 27, 2015Estimated
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
Sep 16, 2025
Last Update Posted Date
Oct 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
Detailed Description
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Conditions Module
Conditions
Thyroid Cancer
Keywords
medullary thyroid cancer
metastatic
thyroid cancer
carcinoma of the thyroid
receptor tyrosine kinase inhibitor
VEGFR
Unresectable locally advanced thyroid cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
81Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
300mg vandetanib
Active Comparator
Drug: 300mg vandetanib
150mg vandetanib
Active Comparator
Drug: 150mg vandetanib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
300mg vandetanib
Drug
Oral blinded tablets taken once daily.
At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment
Dosing with unblinded study treatment can continue until 24 months after patient was randomised.
At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Randomisation to week 60 (maximum)
Secondary Outcomes
Measure
Description
Time Frame
Best Objective Response
Randomisation to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Randomization to Week 60 (maximum)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
Lesions must be amenable to accurate and repeat measurement.
Exclusion Criteria:
Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
For women only - currently pregnant or breast feeding.
93 participants were screened; 81 participants were randomized to treatment. Participants with objective disease progression within the 14 months on blinded treatment were given the option to continue to receive vandetanib in open-label period for up to 2 years from the time of study entry. Participants were followed for efficacy during the randomized period only. No further efficacy data was collected in open-label period as pre-specified in the protocol.
Recruitment Details
From 8 June 2012 to 2 April 2014, 81 participants were randomized by 29 centers in 9 global countries. The study consisted of a double-blind randomized period and an open-label period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Randomized Period: Vandetanib 150 mg
Oral blinded tablet, taken once daily
FG001
Randomized Period: Vandetanib 300 mg
Oral blinded tablet, taken once daily
Periods
Title
Milestones
Reasons Not Completed
Randomized Period (up to 14 Months)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Germany
Taiwan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
300mg vandetanib
SAR390530
150mg vandetanib
Drug
Oral blinded tablets taken once daily.
At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg
Dosing with unblinded study treatment can continue until 24 months after patient was randomised
At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) [OR 300 reduced to 200mg/day if dose was increased at unblinding.] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
150mg vandetanib
SAR390530
Time to Objective Response (RECIST 1.1) by Treatment Arm
Randomization to Week 60 (maximum)
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Randomization to Week 60 (maximum)
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Week 3 to week 60 (maximum)
Olomouc
77900
Czechia
Research Site
Olomouc
Czechia
Investigational Site Number : 1901
Prague
15006
Czechia
Research Site
Prague
Czechia
Research Site
Bangalore Karnataka
India
Research Site
Vellore
India
Research Site
Beersheba
Israel
Research Site
Haifa
Israel
Research Site
Jerusalem
Israel
Research Site
Petah Tikva
Israel
Research Site
Catania
Italy
Research Site
Milan
Italy
Research Site
Palermo
Italy
Research Site
Pisa
Italy
Research Site
Roma
Italy
Research Site
Siena
Italy
Research Site
Torino
Italy
Research Site
Groningen
Netherlands
Research Site
Leiden
Netherlands
Investigational Site Number : 5704
Warsaw
Masovian Voivodeship
02-781
Poland
Investigational Site Number : 5703
Gliwice
44-101
Poland
Research Site
Gliwice
Poland
Research Site
Warsaw
Poland
Research Site
Zgierz
Poland
Research Site
Saint Petersburg
Russia
Research Site
Cardiff
United Kingdom
Research Site
Greater London
United Kingdom
Research Site
London
United Kingdom
Research Site
Tyne & Wear
United Kingdom
FG002
Open-label Period: Vandetanib 100 mg
Participants who received vandetanib 150 milligrams (mg) orally once daily but the dose was reduced to vandetanib 100 mg orally once daily for an adverse event (AE) or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 100 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
FG003
Open-label Period: Vandetanib 150 mg
Participants who received vandetanib 150 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to stay on vandetanib 150 mg orally once daily in open-label period for a maximum of 2 years from study entry.
FG004
Open-label Period: Vandetanib 200 mg
Participants who received vandetanib 300 mg orally once daily but the dose was reduced to vandetanib 200 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 200 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
FG005
Open-label Period: Vandetanib 300 mg
Participants who received vandetanib 150 mg or 300 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to increase or continue vandetanib 300 mg orally once daily in open-label period respectively for a maximum of 2 years from study entry.
FG00040 subjects
FG00141 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
Completed treatment
FG00035 subjects
FG00126 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0005 subjects
FG00115 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Condition Under Investigation Worsened
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Study-specific Discontinuation Criteria
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant Decision
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Open-Label Period (Month 14 to 2 Years)
Type
Comment
Milestone Data
STARTED
Started open-label period
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0039 subjects
FG0048 subjects
FG00539 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0037 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Study-specific Withdrawal Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
BG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00141
BG00281
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00052.2± 15.24
BG00152.7± 15.42
BG00252.5± 15.24
Age, Customized
Number
Participants
Title
Denominators
Categories
>=18 to <40 years
Title
Measurements
BG0009
BG0019
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00112
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0001
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR
Posted
Number
95% Confidence Interval
Proportion of participants
Randomisation to week 60 (maximum)
ID
Title
Description
OG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
OG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
Units
Counts
Participants
OG00040
OG00141
Title
Denominators
Categories
Title
Measurements
OG0000.20(0.105 to 0.348)
OG0010.29(0.176 to 0.445)
Secondary
Best Objective Response
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Posted
Number
Participants
Randomisation to week 60 (maximum)
ID
Title
Description
OG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
OG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
Units
Counts
Participants
OG000
Secondary
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Posted
Median
95% Confidence Interval
Months
Randomization to Week 60 (maximum)
ID
Title
Description
OG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
OG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
Units
Counts
Participants
OG000
Secondary
Time to Objective Response (RECIST 1.1) by Treatment Arm
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Posted
Median
95% Confidence Interval
Months
Randomization to Week 60 (maximum)
ID
Title
Description
OG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
OG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Posted
Mean
Standard Deviation
% change
Randomization to Week 60 (maximum)
ID
Title
Description
OG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
OG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
Units
Counts
Participants
OG000
Secondary
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.
Posted
Mean
Standard Deviation
ng/ml
Week 3 to week 60 (maximum)
ID
Title
Description
OG000
Vandetanib 150 mg
Oral blinded tablet, taken once daily
OG001
Vandetanib 300 mg
Oral blinded tablet, taken once daily
Units
Counts
Participants
OG000
Time Frame
Serious adverse events (SAEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 12 years. Other (non-serious) AEs were reported from randomization (Day 1) up to Week 108 (final analysis visit), 2 years.
Description
Analysis was performed on the safety population which included all participants who received at least 1 dose of randomized study drug (vandetanib) and for whom any post-dose data were available.
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
Randomized Period: Vandetanib 150 mg
Oral blinded tablet, taken once daily
1
40
9
40
38
40
EG001
Randomized Period: Vandetanib 300 mg
Oral blinded tablet, taken once daily
6
41
9
41
40
41
EG002
Open-label Period: Vandetanib 100 mg
Participants who received vandetanib 150 mg orally once daily but the dose was reduced to vandetanib 100 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 100 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
0
5
0
5
5
5
EG003
Open-label Period: Vandetanib 150 mg
Participants who received vandetanib 150 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to stay on vandetanib 150 mg orally once daily in open-label period for a maximum of 2 years from study entry.
0
9
4
9
7
9
EG004
Open-label Period: Vandetanib 200 mg
Participants who received vandetanib 300 mg orally once daily but the dose was reduced to vandetanib 200 mg orally once daily for an AE or QT prolongation in randomized period continued receiving the reduced dose of vandetanib 200 mg orally once daily in open-label period as per the Investigator for a maximum of 2 years from study entry.
1
8
2
8
7
8
EG005
Open-label Period: Vandetanib 300 mg
Participants who received vandetanib 150 mg or 300 mg orally once daily without any dose reduction for an AE or QT prolongation in randomized period were given an option to increase or continue vandetanib 300 mg orally once daily in open-label period respectively for a maximum of 2 years from study entry.
10
39
11
39
31
39
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Myocardial Infarction
Cardiac disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected39 at risk
Angina Pectoris
Cardiac disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac Failure Acute
Cardiac disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Duodenal Ulcer Perforation
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Gastritis Erosive
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Oesophageal Obstruction
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Drug Interaction
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
General Physical Health Deterioration
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Sudden Death
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Abscess
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Diverticulitis
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Neurocysticercosis
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia Aspiration
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Viral Infection
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Post Procedural Fistula
Injury, poisoning and procedural complications
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Post Procedural Haematoma
Injury, poisoning and procedural complications
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Soft Tissue Necrosis
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Adenocarcinoma Pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Benign Laryngeal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Epilepsy
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hemiparesis
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Miller Fisher Syndrome
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Calculus Ureteric
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Laryngeal Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Laryngeal Obstruction
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Laryngeal Oedema
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected39 at risk
Sinus Tachycardia
Cardiac disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0016 events5 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Corneal Opacity
Eye disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0015 events4 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Eye Pain
Eye disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Keratitis
Eye disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Keratopathy
Eye disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0006 events6 affected40 at risk
EG00117 events14 affected41 at risk
EG0023 events2 affected5 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0014 events3 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Anal Fissure
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG00017 events15 affected40 at risk
EG00121 events18 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0014 events4 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0005 events4 affected40 at risk
EG0016 events5 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0006 events5 affected40 at risk
EG0017 events7 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Fatigue
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0008 events8 affected40 at risk
EG0017 events7 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events4 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Oedema Peripheral
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0013 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Influenza
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Lower Respiratory Tract Infection Bacterial
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Paronychia
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia Staphylococcal
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Rash Pustular
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Vulval Abscess
Infections and infestations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Corneal Abrasion
Injury, poisoning and procedural complications
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG0017 events7 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0016 events6 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Blood Creatinine Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0006 events5 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Blood Glucose Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Blood Thyroid Stimulating Hormone Decreased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG00012 events12 affected40 at risk
EG00111 events9 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Ejection Fraction Decreased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Electrocardiogram Qt Prolonged
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG00115 events14 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Platelet Count Decreased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Weight Decreased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0016 events5 affected41 at risk
EG0020 events0 affected5 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0018 events7 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0008 events7 affected40 at risk
EG00111 events10 affected41 at risk
EG0023 events2 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG0018 events7 affected41 at risk
EG0023 events2 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0005 events4 affected40 at risk
EG0019 events6 affected41 at risk
EG0022 events2 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0005 events3 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Metastases To Bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Disturbance In Attention
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Head Titubation
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Headache
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events3 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0016 events6 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0006 events4 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0007 events6 affected40 at risk
EG0014 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dysaesthesia Pharynx
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Lower Respiratory Tract Inflammation
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary Hypertension
Respiratory, thoracic and mediastinal disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0007 events6 affected40 at risk
EG0018 events6 affected41 at risk
EG0021 events1 affected5 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG0015 events5 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0015 events4 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0014 events3 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0009 events8 affected40 at risk
EG00119 events13 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected5 at risk
EG003
Cataract Operation
Surgical and medical procedures
MedDra 12.0 - 25.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected41 at risk
EG0022 events1 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDra 12.0 - 25.1
Systematic Assessment
EG00010 events8 affected40 at risk
EG00114 events11 affected41 at risk
EG0021 events1 affected5 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
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.