A Trial of Panobinostat and Trastuzumab for Adult Female... | NCT00567879 | Trialant
NCT00567879
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
May 9, 2016Estimated
Enrollment
56Actual
Phase
Phase 1Phase 2
Conditions
Breast Cancer
Interventions
Panobinostat
Trastuzumab
Countries
United States
Canada
France
Germany
Italy
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00567879
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLBH589C2204
Secondary IDs
ID
Type
Description
Link
2007-002449-19
EudraCT Number
Brief Title
A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab
Official Title
A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2016
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early due to insufficient evidence of clinical benefit.
Expanded Access Info
No
Start Date
Apr 2008
Primary Completion Date
May 2011Actual
Completion Date
May 2011Actual
First Submitted Date
Dec 4, 2007
First Submission Date that Met QC Criteria
Dec 4, 2007
First Posted Date
Dec 5, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 4, 2016
Results First Submitted that Met QC Criteria
Apr 4, 2016
Results First Posted Date
May 9, 2016Estimated
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
Apr 4, 2016
Last Update Posted Date
May 9, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Detailed Description
This phase Ib/IIa study was prematurely terminated due to lack of efficacy noted in 55 patients with HER2-positive MBC who had progressed on or following a trastuzumab-based therapy.
Conditions Module
Conditions
Breast Cancer
Keywords
Breast Cancer
HER2 positive
adult-female
LBH589
HDAC inhibitor
panobinostat
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
56Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Panobinostat with trastuzumab
Experimental
Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
Drug: Panobinostat
Drug: Trastuzumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Panobinostat
Drug
Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.
day 21
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Best Overall Response
Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion criteria:
Age > 18 year old
Confirmed HER2+ ve metastatic breast cancer
Prior treatment and progression on trastuzumab
Patients must have adequate laboratory values
Eastern Cooperative Oncology Group (ECOG) performance status of <2
Key Exclusion criteria:
Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
Impaired heart function or clinically significant heart disease
Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
Ongoing diarrhea
Liver or renal disease with impaired hepatic or renal functions
Concomitant use of any anti-cancer therapy or certain drugs
Female patients who are pregnant or breast feeding
Patients not willing to use an effective method of birth control
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California at Los Angeles
Los Angeles
California
90095
United States
University of Colorado Dept. of Univ. of Colorado
References Module
Citations
Not provided
See Also Links
Label
URL
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Eligible participants were allocated to dose escalation arm 1 (i.v. panobinostat) or arm 2 (oral panobinostat) according to a pre-determined sequence in the ratio 1:1. Each cohort consisted of newly enrolled participants. This study included a dose escalation phase to establish the maximum tolerated dose (MTD) and a dose expansion phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Escalation: i.v. Arm - 10mg/m^2
10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
FG001
Escalation: i.v. Arm - 15mg/m^2
15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Panobinostat with trastuzumab
Trastuzumab
Drug
Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.
Panobinostat with trastuzumab
Herceptin
day 21
Aurora
Colorado
80045
United States
Norwalk Hospital Dept of Norwalk Hospital (2)
Norwalk
Connecticut
06856
United States
VA Maryland Health Care Dept.of GreenbaumCancerCent(3)
Baltimore
Maryland
21201
United States
The Center for Cancer Care and Research
St Louis
Missouri
63141
United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC
Columbus
Ohio
43210
United States
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
FG003
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
FG004
Oral Arm - Schedule B 15 mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
FG005
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
FG0007 subjects
FG0017 subjects
FG00221 subjects7 participants belonged to the dose expansion group at 20mg/m2 i.v.
FG0036 subjects
FG00412 subjects
FG0053 subjects
Maximum Tolerated Dose Determining Set
FG0005 subjects
FG0017 subjects
FG00218 subjects6 participants belonged to the dose expansion group at 20mg/m2 i.v.
FG0036 subjects
FG00412 subjects
FG0053 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0007 subjects
FG0017 subjects
FG00221 subjects
FG0036 subjects
FG00412 subjects
FG0053 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Abnormal test procedure(s)
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
New cancer therapy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Disease progression
FG0005 subjects
FG0017 subjects
FG00215 subjects
FG0035 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Escalation: i.v. Arm - 10mg/m^2
10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
BG001
Escalation: i.v. Arm - 15mg/m^2
15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
BG002
Escalation/Expansion: i.v. Arm -20mg/m^2
20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
BG003
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
BG004
Oral Arm - Schedule B 15mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
BG005
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0017
BG00221
BG0036
BG00412
BG0053
BG00656
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00058.0(35.0 to 60.0)
BG00149.0(33.0 to 60.0)
BG00257.0(37.0 to 83.0)
BG003
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG0007
BG0017
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
Number of Participants With Dose Limiting Toxicities (DLTs)
Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.
The Maximum Tolerated Dose (MTD) determining set was used for this analysis. The MTD determining set consisted of all participants who either received sufficient study drug and had sufficient safety evaluations or discontinued due to unacceptable toxicity.
Posted
Number
Participants
day 21
ID
Title
Description
OG000
Escalation: i.v. Arm - 10mg/m^2
10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG001
Escalation: i.v. Arm - 15mg/m^2
15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG002
Escalation/Expansion: i.v. Arm -20mg/m^2
20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG003
Expansion: i.v. Arm -20mg/m^2
20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG004
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
OG005
Oral Arm - Schedule B 15 mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
OG006
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Units
Counts
Participants
OG0005
OG0017
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Number of Participants With Best Overall Response
Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
The full analysis set was analyzed. The full analysis set included all randomized participants.
Posted
Number
Participants
day 21
ID
Title
Description
OG000
Escalation: i.v. Arm - 10mg/m^2
10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG001
Escalation: i.v. Arm - 15mg/m^2
15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG002
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Escalation: i.v. Arm - 10mg/m^2
10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
3
7
7
7
EG001
Escalation: i.v. Arm - 15mg/m^2
15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1
7
7
7
EG002
Escalation/Expansion: i.v. Arm -20mg/m^2
20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
5
21
21
21
EG003
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
3
6
6
6
EG004
Oral Arm - Schedule B 15 mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
2
12
12
12
EG005
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG0030 affected6 at risk
EG0040 affected12 at risk
EG0050 affected3 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Visual impairment
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Oedematous pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Pancreatic duct obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
General physical health deterioration
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Blood amylase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected21 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0023 affected21 at risk
EG0030 affected6 at risk
EG0040 affected12 at risk
EG0050 affected3 at risk
Anisocytosis
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0020 affected21 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0013 affected7 at risk
EG0023 affected21 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0029 affected21 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Cardiac flutter
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0022 affected21 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0020 affected21 at risk
EG003
Dry eye
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected21 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0022 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0024 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0028 affected21 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0024 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected21 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0004 affected7 at risk
EG0015 affected7 at risk
EG00214 affected21 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0012 affected7 at risk
EG0025 affected21 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0027 affected21 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0005 affected7 at risk
EG0014 affected7 at risk
EG0024 affected21 at risk
EG003
Catheter site erythema
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0022 affected21 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0023 affected21 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0013 affected7 at risk
EG0027 affected21 at risk
EG003
Gait disturbance
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Influenza like illness
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0025 affected21 at risk
EG003
Irritability
General disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Mucosal inflammation
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0024 affected21 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected21 at risk
EG003
Thrombosis in device
General disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hordeolum
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected21 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected21 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0023 affected21 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Blood amylase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0003 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Blood urine present
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram QT shortened
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram ST segment abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Neutrophil count increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Weight decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
White blood cell count increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0028 affected21 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0023 affected21 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0023 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0024 affected21 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0023 affected21 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected7 at risk
EG0012 affected7 at risk
EG0026 affected21 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0025 affected21 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG00210 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0004 affected7 at risk
EG0016 affected7 at risk
EG0027 affected21 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Agitation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0012 affected7 at risk
EG0021 affected21 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Breast discharge
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Breast haemorrhage
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0011 affected7 at risk
EG0027 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0013 affected7 at risk
EG0027 affected21 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Lividity
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Nail toxicity
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0012 affected7 at risk
EG0022 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0021 affected21 at risk
EG003
Hot flush
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0020 affected21 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0021 affected21 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected7 at risk
EG0022 affected21 at risk
EG003
Phlebitis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected7 at risk
EG0020 affected21 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis
862-778-8300
ID
Term
D001943
Breast Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077767
Panobinostat
D000068878
Trastuzumab
Ancestor Terms
ID
Term
D006877
Hydroxamic Acids
D006898
Hydroxylamines
D000588
Amines
D009930
Organic Chemicals
D006880
Hydroxy Acids
D002264
Carboxylic Acids
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
11 subjects
FG0053 subjects
54.5
(49.0 to 59.0)
BG00453.5(40.0 to 65.0)
BG00547.0(38.0 to 60.0)
BG00653.0(33.0 to 83.0)
21
BG0036
BG00412
BG0053
BG00656
6
OG0046
OG00512
OG0063
1
OG0041
OG0053
OG0061
Escalation/Expansion: i.v. Arm -20mg/m^2
20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
OG003
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
OG004
Oral Arm - Schedule B 15 mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
OG005
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.