Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab... | NCT03780010 | Trialant
NCT03780010
Sponsor
Tracon Pharmaceuticals Inc.
Status
Completed
Last Update Posted
Oct 28, 2019Actual
Enrollment
15Actual
Phase
Phase 1
Conditions
Non Small Cell Lung Cancer
Interventions
TRC105
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03780010
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
105LC101
Secondary IDs
Not provided
Brief Title
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
Official Title
A Phase 1b Dose-escalation Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Patients With Stage 4 Non-Squamous Cell Lung Cancer
Acronym
Not provided
Organization
Tracon Pharmaceuticals Inc.INDUSTRY
Status Module
Record Verification Date
Oct 2019
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
Sep 2015Actual
Primary Completion Date
Jun 2019Actual
Completion Date
Jun 2019Actual
First Submitted Date
Nov 13, 2018
First Submission Date that Met QC Criteria
Dec 17, 2018
First Posted Date
Dec 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 8, 2019
Results First Submitted that Met QC Criteria
Oct 4, 2019
Results First Posted Date
Oct 28, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 4, 2019
Last Update Posted Date
Oct 28, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tracon Pharmaceuticals Inc.INDUSTRY
Collaborators
Name
Class
University of Alabama at Birmingham
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Detailed Description
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC) patients when given with carboplatin and paclitaxel. TRC105 is an antibody to endoglin, an essential angiogenic target expressed on proliferating endothelial cells that is distinct from the VEGFR and overexpressed in response to VEGF inhibition. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models and complements the activity of antibodies and small molecules that target the VEGFR. In a phase 1b study, the combination of TRC105 and bevacizumab produced radiographic reductions in tumor volume in bevacizumab-refractory patients, and was well tolerated. TRC105 was also well tolerated with chemotherapy in a trial with capecitabine in breast cancer patients. The use of TRC105 with bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin alone.
Conditions Module
Conditions
Non Small Cell Lung Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
15Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TRC105 + B + P + C
Experimental
TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Drug: TRC105
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TRC105
Drug
Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
TRC105 + B + P + C
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Treatment-Emergent Adverse Events
Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
from screening until completion of follow-up, on average 6 months
Secondary Outcomes
Measure
Description
Time Frame
Overall RECIST 1.1 Response Rate
Response rate determined according to RECIST 1.1 criteria
6 months
Percent of Patients With Progression-free Survival (PFS) at 6 Months
Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor)
ECOG performance status ≤ 1
Measurable disease by RECIST
Key Exclusion Criteria:
Non-small cell lung cancer of squamous histology
Current treatment on another therapeutic clinical trial
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.
Dose Level 1: 8 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC
Dose Level 2: 10 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC
Dose Level 1: 8 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 0.00-0.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Median duration of progression free survival according to RECIST 1.1 criteria
months
Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin
Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.
3 months
Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
6 months
Dose Level 2: 10 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
BG002
Total
Total of all reporting groups
3
BG00112
BG00215
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00069(56 to 75)
BG00170(45 to 82)
BG00269(45 to 82)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0016
BG0028
Male
BG0001
BG0016
BG0027
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
Not Hispanic or Latino
BG0003
BG00112
BG00215
Unknown or Not Reported
BG0000
BG0010
BG0020
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
Asian
BG0000
BG0011
BG0021
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG0000
BG0012
BG0022
White
BG0003
BG0019
BG00212
More than one race
BG0000
BG0010
BG0020
Unknown or Not Reported
BG0000
BG0010
BG0020
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG00112
BG00215
Number of prior regimens
Median
Full Range
number of prior regimens
Title
Denominators
Categories
Title
Measurements
BG0000(0 to 0)
BG0010(0 to 0)
BG0020(0 to 0)
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
Participants who experienced an AE
Title
Measurements
OG0003
OG00112
Participants who experienced a TRC105 related AE
Title
Measurements
OG0003
OG00111
Participants who experienced a Bev related AE
Title
Measurements
OG0003
OG00110
Participants who experienced a Carbo related AE
Title
Measurements
OG0003
OG00112
Participants who experienced a Pac related AE
Title
Measurements
OG0003
OG00112
Secondary
Overall RECIST 1.1 Response Rate
Response rate determined according to RECIST 1.1 criteria
Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination
Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 1.00-1.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 2.00-2.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 3.00-3.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 4.00-4.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 5.00-5.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 6.00-6.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 7.0-7.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 8.0-8.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 9.0-9.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 at a dosage of 10.00 mg/kg at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
0
1
0
1
1
1
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hematemesis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Non Cardiac Chest Pain
General disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypertensive Encephalopathy
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Altered Mental Status
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypoxemia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Sepsis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Pneumonia
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Left arm wound infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Left forearm wound/degloving injury
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Febrile Neutropenic Sepsis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Weakness
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Abdominal Discomfort
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Abrasions arms and face
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Acneform rash, scalp
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Acneiform rash, face
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Allergic Rhinitis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Allergy symptoms, sneezing
Immune system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0031 events1 affected5 at risk
EG0043 events3 affected6 at risk
EG0053 events3 affected9 at risk
EG0062 events2 affected5 at risk
EG0072 events2 affected5 at risk
EG0082 events2 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Anal hemorrhage
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Anemia
Blood and lymphatic system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0035 events2 affected5 at risk
EG0040 events0 affected6 at risk
EG00513 events2 affected9 at risk
EG0065 events2 affected5 at risk
EG0072 events1 affected5 at risk
EG0084 events3 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Ankle edema
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Anorexia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0003 events3 affected15 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0053 events2 affected9 at risk
EG0063 events2 affected5 at risk
EG0074 events2 affected5 at risk
EG0086 events3 affected5 at risk
EG0091 events1 affected2 at risk
EG0102 events1 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0008 events4 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0044 events2 affected6 at risk
EG00512 events2 affected9 at risk
EG0061 events1 affected5 at risk
EG0075 events2 affected5 at risk
EG0087 events2 affected5 at risk
EG0091 events1 affected2 at risk
EG0101 events1 affected1 at risk
Arthralgia Knees
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Arthralgias
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0007 events4 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG00812 events2 affected5 at risk
EG0091 events1 affected2 at risk
EG0101 events1 affected1 at risk
Atrial Fibrillation
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Auditory Hallucinations
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Belching
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Bilateral Ankle edema
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Bladder infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Bleeding gums
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected12 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Bleeding hemorrhoids
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Blood in sputum
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Blood with sinus drainage
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Bronchitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Central chest pain
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Chest Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Chest Pain
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Chest Pain non cardiac
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Chills
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Clostridium Difficile Infection
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Cold intolerance
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Cold Sores
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Cold Symptoms
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Confusion
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Constipation
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0083 events2 affected5 at risk
EG0092 events2 affected2 at risk
EG0100 events0 affected1 at risk
Constipation intermittent
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
COPD Exacerbation
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0065 events2 affected5 at risk
EG0070 events0 affected5 at risk
EG0084 events2 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Cramps Extremities
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Decreased Platelet Count
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Depression
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Diarrhea
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0004 events2 affected15 at risk
EG0010 events0 affected1 at risk
EG0026 events5 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0059 events3 affected9 at risk
EG0063 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG00810 events3 affected5 at risk
EG0092 events1 affected2 at risk
EG0100 events0 affected1 at risk
Diarrhea, Intermittent
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dizziness
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0082 events2 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Dizziness upon rising
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dry Eyes
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Dry Mouth
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dry Skin, Face
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dry, hyperpigmented skin - posterior neck
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Dysgeusia
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0005 events5 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0073 events3 affected5 at risk
EG0082 events2 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0082 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Dysuria
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Earache
Ear and labyrinth disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Elevated TSH
Investigations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Emesis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0042 events2 affected6 at risk
EG0051 events1 affected9 at risk
EG0061 events1 affected5 at risk
EG0072 events2 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Encephalopathy
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0087 events2 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected1 at risk
EG0025 events2 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0059 events4 affected9 at risk
EG0065 events3 affected5 at risk
EG0073 events2 affected5 at risk
EG0088 events2 affected5 at risk
EG0091 events1 affected2 at risk
EG0101 events1 affected1 at risk
Erythema, palms
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0042 events1 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Erythematous Rash, both hands
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Eye floaters
Eye disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Facial Cellulitis
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Facial Numbness
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Fall
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Fatigue
General disorders
MedDRA (14.1)
Systematic Assessment
EG0006 events5 affected15 at risk
EG0011 events1 affected1 at risk
EG0023 events3 affected12 at risk
EG0033 events2 affected5 at risk
EG0046 events3 affected6 at risk
EG00515 events3 affected9 at risk
EG0068 events3 affected5 at risk
EG00713 events3 affected5 at risk
EG00831 events5 affected5 at risk
EG00911 events2 affected2 at risk
EG0101 events1 affected1 at risk
Fever
General disorders
MedDRA (14.1)
Systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Flatulence
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Flu like symptoms
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Flushing
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0002 events2 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Generalized weakness
General disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Gingival abscess
Infections and infestations
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Gingival Bleeding
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Gingival Ulcer
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Gingivitis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Gum Bleeding
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Hair Loss
Skin and subcutaneous tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Hand tremors
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Headache
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0003 events3 affected15 at risk
EG0011 events1 affected1 at risk
EG0027 events6 affected12 at risk
EG0031 events1 affected5 at risk
EG0044 events2 affected6 at risk
EG0055 events2 affected9 at risk
EG0063 events2 affected5 at risk
EG00722 events1 affected5 at risk
EG00814 events2 affected5 at risk
EG0093 events2 affected2 at risk
EG0102 events1 affected1 at risk
Heartburn
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hematemesis
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hematuria
Renal and urinary disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0082 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hemorrhoids
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hip pain
Musculoskeletal and connective tissue disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Hoarseness
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypernatremia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypertension
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Hypokalemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypomagnesemia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0072 events2 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
Hyponatremia
Metabolism and nutrition disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Hypotension
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypothyroidism
Endocrine disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Hypoxemia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypoxemic Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0052 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Increased Phlegm
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Infusion Reaction
Injury, poisoning and procedural complications
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Insomnia
Psychiatric disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent atrial fibrillation
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent Constipation
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent Hypotension
Vascular disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent left lower quadrant abdominal pain
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent Diarrhea
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent headaches
Nervous system disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent shortness of breath
Respiratory, thoracic and mediastinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent tachycardia
Cardiac disorders
MedDRA (14.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
Intermittent Constipation
Gastrointestinal disorders
MedDRA (14.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
IV infiltration during pre-med Emend administration