A Dose-ranging Study to Evaluate the Safety and Efficacy... | NCT04806503 | Trialant
NCT04806503
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Jun 20, 2024Actual
Enrollment
234Actual
Phase
Phase 2
Conditions
Presbyopia
Interventions
UNR844
Placebo
Countries
United States
Australia
Canada
Japan
Protocol Section
Identification Module
NCT ID
NCT04806503
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CUNR844A2202
Secondary IDs
Not provided
Brief Title
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Official Title
A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
Acronym
READER
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was discontinued by the Sponsor because it did not achieve the primary objective.
Expanded Access Info
No
Start Date
Jun 30, 2021Actual
Primary Completion Date
Jul 27, 2022Actual
Completion Date
Oct 14, 2022Actual
First Submitted Date
Mar 16, 2021
First Submission Date that Met QC Criteria
Mar 16, 2021
First Posted Date
Mar 19, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jul 14, 2023
Results First Submitted that Met QC Criteria
Aug 7, 2023
Results First Posted Date
Aug 30, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 1, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Aug 30, 2023Actual
Last Update Submitted Date
Jun 17, 2024
Last Update Posted Date
Jun 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
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
Study of safety and efficacy of UNR844 in subjects with presbyopia.
Detailed Description
This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of:
A 1 week run-in period
A 3-month treatment course with UNR844 and/or Placebo
A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months.
Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline.
This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.
Conditions Module
Conditions
Presbyopia
Keywords
loss of elasticity in lens
lens
lens disorder
loss of near vision
Presbyopia
UNR844
farsightedness
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
234Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
UNR844 5 mg/mL
Experimental
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
UNR844 13.3 mg/mL
Experimental
UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
UNR844 23 mg/mL
Experimental
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
UNR844 30 mg/mL
Experimental
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Placebo Ophthalmic Solution
Placebo Comparator
placebo ophthalmic solution; one drop twice-a-day for three months
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
UNR844
Drug
Ophthalmic solution for topical ocular administration
UNR844 13.3 mg/mL
UNR844 23 mg/mL
UNR844 30 mg/mL
UNR844 5 mg/mL
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Baseline, Month 3
Secondary Outcomes
Measure
Description
Time Frame
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed
Impaired near vision in each eye and when using both eyes, without any near correction
Need a certain level of near correction
Exclusion Criteria:
Impaired distance vision in either eye, with distance correction (if any)
Severe short- or long-sightedness
Any significant medical or clinical conditions affecting vision, the eyes or general health
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
FG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
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
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 3, 2021
Jul 14, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
EV06
Placebo
Drug
Placebo
Placebo Ophthalmic Solution
Vehicle
Baseline, Month 3
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Baseline, Month 3
Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Baseline, Month 3
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Baseline, Month 3
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
FG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
FG004
Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
FG00048 subjects
FG00148 subjects
FG00244 subjects
FG00348 subjects
FG00446 subjects
COMPLETED
FG00046 subjects
FG00147 subjects
FG00242 subjects
FG00346 subjects
FG00445 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0041 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
BG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
BG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
BG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
BG004
Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00048
BG00148
BG00244
BG00348
BG00446
BG005234
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050.8± 2.61
BG00150.9± 2.80
BG00251.0± 2.94
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00128
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Full Analysis Set
Posted
Least Squares Mean
Standard Error
logMAR
Baseline, Month 3
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG004
Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
Units
Counts
Participants
OG00048
OG00148
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.106± 0.0186
OG001-0.110± 0.0188
OG002-0.136± 0.0203
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed-effect Model for Repeated Measures
0.817
Least Squares Mean
0.006
Standard Error of the Mean
0.0258
2-Sided
95
-0.045
0.056
Other
Mixed-effect Model for Repeated Measures model-based two-sided t-test
OG001
OG004
Mixed-effect Model for Repeated Measures
Secondary
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Full Analysis Set
Posted
Least Squares Mean
Standard Error
logMAR
Baseline, Month 3
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Secondary
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Full Analysis Set
Posted
Least Squares Mean
Standard Error
logMAR
Baseline, Month 3
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Secondary
Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Full Analysis Set
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, Month 3
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
Secondary
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Full Analysis Set
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, Month 3
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
Secondary
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Full Analysis Set
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, Month 3
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
Post-Hoc
All Collected Deaths
On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum timeframe of approx. 4 months.
Post-treatment deaths were collected from day 31 after last dose of study medication to end of study, up to approx. 1 year and 1 month.
All deaths refer to the sum of on-treatment and post-treatment deaths.
Safety Set
Posted
Count of Participants
Participants
On-treatment: up to 121 days, approx. 4 months. Off treatment: up to approx. 1 year and 1 month
ID
Title
Description
OG000
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
OG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Time Frame
Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
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
UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
0
48
0
48
26
48
EG001
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months
0
48
1
48
22
48
EG002
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
0
44
0
44
16
44
EG003
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
0
48
1
48
23
48
EG004
Placebo
Placebo ophthalmic solution; one drop twice-a-day for three months
1
46
3
46
21
46
EG005
Total
Total
1
234
5
234
108
234
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG0030 affected48 at risk
EG0040 affected46 at risk
EG0051 affected234 at risk
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Pancreatic cystadenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Myelitis transverse
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG0030 affected48 at risk
EG004
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Asthenopia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Blepharitis
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0021 affected44 at risk
EG003
Central serous chorioretinopathy
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Chalazion
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0023 affected44 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Corneal epithelium defect
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Dry eye
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0021 affected44 at risk
EG003
Episcleritis
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Eye irritation
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Eye pain
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0021 affected44 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Eyelid cyst
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Eyelid rash
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Eyelid skin dryness
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Narrow anterior chamber angle
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Noninfective conjunctivitis
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Vision blurred
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Dental cyst
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Feeling hot
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Influenza like illness
General disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Injection site pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Malaise
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Pyrexia
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0012 affected48 at risk
EG0021 affected44 at risk
EG003
Sensation of foreign body
General disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG00015 affected48 at risk
EG00110 affected48 at risk
EG0025 affected44 at risk
EG003
Cystitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Influenza
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0013 affected48 at risk
EG0022 affected44 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Otitis media
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Peritonsillitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Rocky mountain spotted fever
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0002 affected48 at risk
EG0010 affected48 at risk
EG0022 affected44 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0021 affected44 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Hormone level abnormal
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Lipase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Vertebral osteophyte
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Blepharal papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Osteoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Bell's palsy
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0014 affected48 at risk
EG0022 affected44 at risk
EG003
Migraine
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Spinal meningeal cyst
Nervous system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0012 affected48 at risk
EG0020 affected44 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0020 affected44 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Menopause
Social circumstances
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Hot flush
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0011 affected48 at risk
EG0020 affected44 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected48 at risk
EG0010 affected48 at risk
EG0021 affected44 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.