Study of Losartan in Pediatric Patients With Hypertension... | NCT00756938 | Trialant
NCT00756938
Sponsor
Organon and Co
Status
Completed
Last Update Posted
Jun 18, 2024Actual
Enrollment
101Actual
Phase
Phase 3
Conditions
Hypertension
Interventions
losartan potassium
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00756938
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0954-337
Secondary IDs
ID
Type
Description
Link
2008_545
Other Identifier
Merck Study Number
CTRI/2009/091/000045
Registry Identifier
CTRI
Brief Title
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
Official Title
A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension
Acronym
Not provided
Organization
Organon and CoINDUSTRY
Status Module
Record Verification Date
Feb 2022
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
Mar 1, 2009Actual
Primary Completion Date
Aug 14, 2012Actual
Completion Date
Aug 14, 2012Actual
First Submitted Date
Sep 18, 2008
First Submission Date that Met QC Criteria
Sep 19, 2008
First Posted Date
Sep 22, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 16, 2014
Results First Submitted that Met QC Criteria
Jan 16, 2014
Results First Posted Date
Mar 3, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 1, 2013
Certification/Extension First Submitted that Passed QC Review
Aug 1, 2013
Certification/Extension First Posted Date
Aug 8, 2013Estimated
Last Update Submitted Date
Jun 5, 2024
Last Update Posted Date
Jun 18, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Organon and CoINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
Detailed Description
Not provided
Conditions Module
Conditions
Hypertension
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Losartan potassium 0.1 to 1.4 mg/kg
Experimental
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Drug: losartan potassium
Losartan potassium 0.3 to 1.4 mg/kg
Experimental
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Drug: losartan potassium
Losartan potassium 0.7 to 1.4 mg/kg
Experimental
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Drug: losartan potassium
Interventions
Name
Type
Description
Arm Group Labels
Other Names
losartan potassium
Drug
losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Systolic Blood Pressure
Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Baseline and Day 21
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
up to 12 weeks (Base Study); up to 24 months (Extension)
Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
up to 12 weeks (Base Study); up to 24 months (Extension)
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Diastolic Blood Pressure
Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant is determined to be hypertensive
Exclusion Criteria:
Participant has a history of severe or symptomatic hypertension
Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
Participant has started taking hypertensive medications within the past 30 days
Participant has a known sensitivity to losartan or history of angioneurotic edema
Webb NJ, Wells TG, Shahinfar S, Massaad R, Dankner WM, Lam C, Santoro EP, McCrary Sisk C, Blaustein RO. A randomized, open-label, dose-response study of losartan in hypertensive children. Clin J Am Soc Nephrol. 2014 Aug 7;9(8):1441-8. doi: 10.2215/CJN.11111113. Epub 2014 May 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Losartan Potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
FG001
Losartan Potassium 0.3 to 1.4 mg/kg
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
FG002
Losartan Potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
FG003
Losartan Potassium-Extension
Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
Periods
Title
Milestones
Reasons Not Completed
12-week Base Study
Type
Comment
Milestone Data
STARTED
FG00033 subjects
FG00134 subjects
FG00234 subjects
FG0030 subjects
COMPLETED
FG00031 subjects
FG00134 subjects
FG00232 subjects
FG0030 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Type
Comment
Reasons
Protocol-specific Criteria Met
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG003
Optional Extension
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Losartan Potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
BG001
Losartan Potassium 0.3 to 1.4 mg/kg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Mean Change From Baseline in Systolic Blood Pressure
Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation
Posted
Mean
Standard Deviation
mmHg
Baseline and Day 21
ID
Title
Description
OG000
Losartan Potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Adverse Events Module
Frequency Threshold
5
Time Frame
up to 12 weeks (Base Study); up to 24 months (Extension)
Description
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
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
Base Study-Losartan Potassium 0.1 mg/kg/Day
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Enteritis
Gastrointestinal disorders
MedDRA v15.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Conjunctivitis
Eye disorders
MedDRA v15.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Argentina
Brazil
Chile
Colombia
Guatemala
Hungary
India
Lithuania
Norway
Philippines
Romania
Russia
Spain
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006973
Hypertension
Ancestor Terms
ID
Term
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D019808
Losartan
Ancestor Terms
ID
Term
D001713
Biphenyl Compounds
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Losartan potassium 0.1 to 1.4 mg/kg
Losartan potassium 0.3 to 1.4 mg/kg
Losartan potassium 0.7 to 1.4 mg/kg
Cozaar
Baseline and Day 21
0 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
90 subjects
7 participants who completed base study opted not to enter extension
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00353 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00337 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
End of Study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00311 subjects
Protocol-specific criteria met
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0039 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
BG002
Losartan Potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
BG003
Total
Total of all reporting groups
33
BG00134
BG00234
BG003101
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00040.2± 24.4
BG00145.0± 21.5
BG00240.6± 21.2
BG00342.0± 22.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00116
BG00214
BG00343
Male
BG00020
BG00118
BG00220
BG00358
OG001
Losartan Potassium 0.3 to 1.4 mg/kg
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
OG002
Losartan Potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Units
Counts
Participants
OG00032
OG00134
OG00233
Title
Denominators
Categories
Title
Measurements
OG000-7.31± 12.53
OG001-7.65± 7.49
OG002-6.67± 7.86
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
OG001
OG002
ANCOVA
Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage
0.753
Slope
1.22
2-Sided
95
-6.45
8.90
Superiority or Other (legacy)
Secondary
Mean Change From Baseline in Diastolic Blood Pressure
Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation
Posted
Mean
Standard Deviation
mmHg
Baseline and Day 21
ID
Title
Description
OG000
Losartan Potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
OG001
Losartan Potassium 0.3 to 1.4 mg/kg
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
OG002
Losartan Potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Units
Counts
Participants
OG00032
OG00134
OG00233
Title
Denominators
Categories
Title
Measurements
OG000-8.25± 11.76
OG001-5.15± 8.06
OG002-6.73± 8.59
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
OG001
OG002
ANCOVA
Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage
0.643
Slope
1.81
2-Sided
95
-5.90
9.51
Superiority or Other (legacy)
Primary
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.
Posted
Number
Participants
up to 12 weeks (Base Study); up to 24 months (Extension)
ID
Title
Description
OG000
Base Study-Losartan Potassium 0.1 mg/kg
Open-label Losartan 0.1 mg/kg/day
OG001
Base Study-Losartan Potassium 0.3 mg/kg
Open-label Losartan 0.3 mg/kg/day
OG002
Base Study-Losartan Potassium 0.7 mg/kg
Open-label Losartan 0.7 mg/kg/day
OG003
Base Study-Losartan Potassium 1.4 mg/kg
Open-label losartan 1.4 mg/kg/day
OG004
Extension-Losartan Potassium
Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
Units
Counts
Participants
OG00034
OG00154
OG00263
OG003
Title
Denominators
Categories
Clinical Adverse Event
Title
Measurements
OG00021
OG00130
OG00236
OG003
Primary
Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.
Posted
Number
Participants
up to 12 weeks (Base Study); up to 24 months (Extension)
ID
Title
Description
OG000
Base Study-Losartan Potassium 0.1 mg/kg
Open-label Losartan 0.1 mg/kg/day
OG001
Base Study-Losartan Potassium 0.3 mg/kg
Open-label Losartan 0.3 mg/kg/day
OG002
Base Study-Losartan Potassium 0.7 mg/kg
Open-label Losartan 0.7 mg/kg/day
OG003
Base Study-Losartan Potassium 1.4 mg/kg
Open-label losartan 1.4 mg/kg/day
OG004
Extension-Losartan Potassium
Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
Units
Counts
Participants
OG00034
OG00154
OG00263
OG003
Title
Denominators
Categories
Clinical Adverse Event
Title
Measurements
OG0000
OG0010
OG0020
OG003
3
34
15
34
EG001
Base Study-Losartan Potassium 0.3 mg/kg/Day
2
54
22
54
EG002
Base Study-Losartan Potassium 0.7 mg/kg/Day
2
63
23
63
EG003
Base Study-Losartan 1.4 mg/kg/Day
0
33
17
33
EG004
Extension-Losartan 0.1 mg/kg/Day
3
15
12
15
EG005
Extension-Losartan 0.3 mg/kg/Day
5
28
20
28
EG006
Extension-Losartan 0.7 mg/kg/Day
2
31
20
31
EG007
Extension-Losartan 1.4 mg/kg/Day
5
42
28
42
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Gastritis
Gastrointestinal disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Asthenia
General disorders
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Adenoiditis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0061 events1 affected31 at risk
EG0070 events0 affected42 at risk
Bronchopneumonia
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Conjunctivitis bacterial
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Gastroenteritis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected28 at risk
EG0061 events1 affected31 at risk
EG0071 events1 affected42 at risk
Laryngitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Nasopharyngitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Pneumonia
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Pyelonephritis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Pyelonephritis acute
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0062 events1 affected31 at risk
EG0070 events0 affected42 at risk
Salmonellosis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Sepsis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Sinusitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Urinary tract infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0061 events1 affected31 at risk
EG0071 events1 affected42 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0061 events1 affected31 at risk
EG0070 events0 affected42 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0052 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Nephroblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Psychomotor retardation
Psychiatric disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Renal failure acute
Renal and urinary disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Renal impairment
Renal and urinary disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Ureteric stenosis
Renal and urinary disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
EG0000 events0 affected34 at risk
EG0012 events2 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0042 events2 affected15 at risk
EG0050 events0 affected28 at risk
EG0062 events2 affected31 at risk
EG0072 events1 affected42 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v15.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected28 at risk
EG0061 events1 affected31 at risk
EG0071 events1 affected42 at risk
Constipation
Gastrointestinal disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v15.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0013 events3 affected54 at risk
EG0024 events4 affected63 at risk
EG0032 events2 affected33 at risk
EG0044 events3 affected15 at risk
EG0055 events3 affected28 at risk
EG0065 events5 affected31 at risk
EG0078 events6 affected42 at risk
Vomiting
Gastrointestinal disorders
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected54 at risk
EG0021 events1 affected63 at risk
EG0031 events1 affected33 at risk
EG0040 events0 affected15 at risk
EG0057 events1 affected28 at risk
EG0062 events2 affected31 at risk
EG0073 events3 affected42 at risk
Pyrexia
General disorders
MedDRA v15.0
Systematic Assessment
EG0003 events3 affected34 at risk
EG0016 events4 affected54 at risk
EG0023 events3 affected63 at risk
EG0031 events1 affected33 at risk
EG0041 events1 affected15 at risk
EG0055 events4 affected28 at risk
EG0062 events2 affected31 at risk
EG00710 events4 affected42 at risk
Seasonal allergy
Immune system disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Acute sinusitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Acute tonsillitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0042 events2 affected15 at risk
EG0051 events1 affected28 at risk
EG0061 events1 affected31 at risk
EG0070 events0 affected42 at risk
Bronchitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0012 events2 affected54 at risk
EG0020 events0 affected63 at risk
EG0031 events1 affected33 at risk
EG0040 events0 affected15 at risk
EG0053 events2 affected28 at risk
EG0060 events0 affected31 at risk
EG0072 events2 affected42 at risk
Ear infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0061 events1 affected31 at risk
EG0071 events1 affected42 at risk
Gastroenteritis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0073 events3 affected42 at risk
Gastroenteritis viral
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Impetigo
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0062 events2 affected31 at risk
EG0070 events0 affected42 at risk
Laryngitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Nasopharyngitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0017 events7 affected54 at risk
EG0023 events3 affected63 at risk
EG0033 events2 affected33 at risk
EG0043 events2 affected15 at risk
EG0056 events4 affected28 at risk
EG0066 events5 affected31 at risk
EG0072 events2 affected42 at risk
Oral herpes
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0061 events1 affected31 at risk
EG0070 events0 affected42 at risk
Otitis media acute
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected28 at risk
EG0062 events2 affected31 at risk
EG0073 events2 affected42 at risk
Pharyngitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0003 events3 affected34 at risk
EG0012 events2 affected54 at risk
EG0021 events1 affected63 at risk
EG0031 events1 affected33 at risk
EG0045 events4 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Respiratory tract infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0011 events1 affected54 at risk
EG0026 events5 affected63 at risk
EG0033 events3 affected33 at risk
EG0042 events2 affected15 at risk
EG0053 events3 affected28 at risk
EG0066 events3 affected31 at risk
EG00713 events5 affected42 at risk
Rhinitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0002 events1 affected34 at risk
EG0013 events3 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0054 events1 affected28 at risk
EG0061 events1 affected31 at risk
EG0070 events0 affected42 at risk
Sinusitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0062 events2 affected31 at risk
EG0076 events5 affected42 at risk
Tonsillitis
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0031 events1 affected33 at risk
EG0042 events2 affected15 at risk
EG0052 events1 affected28 at risk
EG0061 events1 affected31 at risk
EG0072 events2 affected42 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0013 events3 affected54 at risk
EG0023 events2 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0054 events4 affected28 at risk
EG0068 events3 affected31 at risk
EG0074 events4 affected42 at risk
Urinary tract infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0003 events2 affected34 at risk
EG0012 events2 affected54 at risk
EG0024 events4 affected63 at risk
EG0034 events4 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG00612 events3 affected31 at risk
EG00713 events7 affected42 at risk
Viral infection
Infections and infestations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0031 events1 affected33 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Animal bite
Injury, poisoning and procedural complications
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0053 events2 affected28 at risk
EG0061 events1 affected31 at risk
EG0070 events0 affected42 at risk
Lip and/or oral cavity cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Headache
Nervous system disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0021 events1 affected63 at risk
EG0031 events1 affected33 at risk
EG0040 events0 affected15 at risk
EG0053 events3 affected28 at risk
EG0060 events0 affected31 at risk
EG0071 events1 affected42 at risk
Enuresis
Renal and urinary disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Nephrocalcinosis
Renal and urinary disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v15.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0013 events2 affected54 at risk
EG0022 events2 affected63 at risk
EG0035 events5 affected33 at risk
EG0041 events1 affected15 at risk
EG0051 events1 affected28 at risk
EG0063 events3 affected31 at risk
EG0079 events5 affected42 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected63 at risk
EG0031 events1 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0012 events2 affected54 at risk
EG0021 events1 affected63 at risk
EG0035 events2 affected33 at risk
EG0042 events2 affected15 at risk
EG0051 events1 affected28 at risk
EG0060 events0 affected31 at risk
EG0074 events4 affected42 at risk
Hypertension
Vascular disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Hypotension
Vascular disorders
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0021 events1 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
Protein urine present
Investigations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0062 events2 affected31 at risk
EG0071 events1 affected42 at risk
Red blood cell count decreased
Investigations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0062 events2 affected31 at risk
EG0070 events0 affected42 at risk
Urine leukocyte esterase positive
Investigations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected28 at risk
EG0062 events2 affected31 at risk
EG0070 events0 affected42 at risk
White blood cells urine positive
Investigations
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected28 at risk
EG0062 events2 affected31 at risk
EG0070 events0 affected42 at risk
Ligament rupture
Injury, poisoning and procedural complications
MedDRA v15.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected54 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected31 at risk
EG0070 events0 affected42 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.