Multi-center Trial in Adult and Pediatric Patients With T... | NCT02748018 | Trialant
NCT02748018
Sponsor
Medtronic MiniMed, Inc.
Status
Completed
Last Update Posted
Aug 19, 2025Actual
Enrollment
959Actual
Phase
Not Applicable
Conditions
Type 1 Diabetes
Interventions
670G and 770G Insulin Pump
Subject's Current Diabetes Therapy
Countries
United States
Canada
France
Germany
Italy
New Zealand
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02748018
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CEP 304
Secondary IDs
Not provided
Brief Title
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
Official Title
Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home
Acronym
Not provided
Organization
Medtronic MiniMed, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 25, 2017Actual
Primary Completion Date
Nov 1, 2023Actual
Completion Date
Nov 1, 2023Actual
First Submitted Date
Apr 19, 2016
First Submission Date that Met QC Criteria
Apr 21, 2016
First Posted Date
Apr 22, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
May 30, 2025
Results First Submitted that Met QC Criteria
Aug 15, 2025
Results First Posted Date
Aug 19, 2025Actual
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
Aug 15, 2025
Last Update Posted Date
Aug 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Medtronic MiniMed, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
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
The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)
Detailed Description
This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with a 6 month continuation period. The study will have three periods, per Cohort:
Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM sensor will be worn for two weeks.
Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control. The primary and secondary endpoints will be evaluated during this period only.
Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode. Only the safety endpoint will be evaluated during this period.
Up to 1500 subjects will be enrolled in order to have 1000 subjects complete the study. Up to 70 investigational Centers in the US, Europe, Canada, Australia and New Zealand will be enrolled.
Conditions Module
Conditions
Type 1 Diabetes
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
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
959Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Hybrid Closed Loop Arm
Experimental
The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.
Device: 670G and 770G Insulin Pump
Control Arm
Active Comparator
The Control Arm will use individual subject's current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump). Each cohort (CSII, MDI, or SAP) will be used as the control arm to be compared to the experimental arm (HCL).
Device: Subject's Current Diabetes Therapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
670G and 770G Insulin Pump
Device
Medtronic 670G and 770G Hybrid Closed Loop Systems
Hybrid Closed Loop Arm
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1C > 8%
Baseline and end of 6-month study period
CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
6 months study period
MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c > 8%
Baseline and end of 6-month study period
MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
6 months study period
SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c > 8%
Baseline and end of 6-month study period
SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
Secondary Outcomes
Measure
Description
Time Frame
CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
6 months study period
CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Subject is age 2-80 years at time of screening
US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study.
Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study.
Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study
Subject has been diagnosed with type 1 diabetes for at least three months Note: Determination of classification for diabetes will be based on American Diabetes Association Clinical Practice Guidelines accounting for several patient characteristics such as: age of onset, patient's weight or BMI, history of diabetic ketoacidosis, history of therapy management, if available in the medical records.
Subject must be on one of the following management therapies:
Multiple daily injections defined by use of rapid analogue with meals and approved long acting analogue (e.g. detemir or glargine) with or without CGM
Insulin pump therapy with or without CGM
Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
Subject is willing to perform required study procedures
Subject is willing to wear the system continuously throughout the study for at least 80% of the time.
Subject is willing to upload data at least weekly from the study pump/meter, must have Internet access and a computer system that meets the requirements for uploading the study pump/meter for data collection
Subject must be willing to use the study glucose meter system (i.e. along with study meter strips).
If subject has celiac disease, it has been adequately treated as determined by the investigator
Subject with the diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease, within 1 year of screening, will be included in the study with the consent of the Investigator
Subject is willing to take one of the following insulins and can financially afford to use either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
Humalog® (insulin lispro injection)
NovoLog® (insulin aspart)
Exclusion Criteria:
Subject participated in any Closed Loop study in the past.
Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement
Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
Subject is being treated for hyperthyroidism at time of screening
Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. TSH is not required for subjects 2-13 years of age.
Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
Subject is currently abusing illicit drugs or marijuana
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening
Subject is using hydroxyurea at the time of screening or plans to use it during the study
Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia
Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
Subjects who are currently being actively treated for cancer.
Subject who is designated as a research staff member for this study
Jendle JH, Garg SK, Thivolet C, Weinstock RS, Hirsch IB, Evans M, Griffin KJ, Philis-Tsimikas A, Wheeler BJ, Kipnes MS, Carlson AL, Buckingham BA, Bhargava A, Bode BW, Lawson ML, Criego AB, McGill JB, Reed JCH, Prakasam G, Grunberger G, Girelli A, Martinez-Brocca MA, Christiansen MP, de Bock MI, Kudva YC, Lee SW, Yovanovich C, Shin JJ, Cordero TL, McVean JJF, Vigersky RA. Automated basal insulin delivery versus multiple daily injections in type 1 diabetes: results from a randomized parallel controlled trial. Front Endocrinol (Lausanne). 2025 Dec 19;16:1716587. doi: 10.3389/fendo.2025.1716587. eCollection 2025.
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
Results Section
Participant Flow Module
Pre-assignment Details
870 (298 in CSII Cohort, 248 in MDI Cohort, 324 in SAP Cohort) subjects entered the study period.
Recruitment Details
Date of first subject enrollment: 25MAY2017, Date of last subject visit (of study period): 09MAY2023 Date of last subject visit (of continuation period): 01NOV2023
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
FG001
CSII Cohort: Control Arm
Periods
Title
Milestones
Reasons Not Completed
Study Period
Type
Comment
Milestone Data
STARTED
Subjects entering the study period (randomized)
Baseline Characteristics Module
Baseline Analysis Population Description
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
Feb 1, 2024
May 30, 2025
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
There will be three cohorts sequentially enrolled for the study. Cohort 1: Continuous Subcutaneous Insulin Infusion (CSII cohort): randomized to HCL (treatment arm) or CSII (Control arm) Cohort 2: Multiple Daily Injections (MDI cohort): randomized to HCL (treatment arm) or MDI (Control arm) Cohort 3: Sensor-Augmented Pump therapy (SAP cohort): randomized to HCL (treatment arm) or SAP (Control arm) Note: Subjects 2-6 years of age will automatically enter the HCL arm at the end of the run-in period
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
Subject's Current Diabetes Therapy
Device
Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).
Control Arm
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
6 months study period
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Baseline and end of 6-month study period
CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
6 months study period
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
6 months study period
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
6 months study period
CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
6 months study period
CSII Cohort: Change in A1C for All Subjects
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Baseline and end of 6-month study period
MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
6 months study period
MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Baseline and end of 6-month study period
MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
6 months study period
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
6 months study period
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
6 months study period
MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
6 months study period
MDI Cohort: Change in A1C for All Subjects
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Baseline and end of 6-month study period
SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
6 months study period
SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Baseline and end of 6-month study period
SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
6 months study period
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
6 months study period
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
6 months study period
SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
6 months study period
SAP Cohort: Change in A1C for All Subjects
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Baseline and end of 6-month study period
Palo Alto
California
94304
United States
Center of Excellence in Diabetes & Endocrinology
Sacramento
California
95821
United States
Sansum Diabetes Research Institute
Santa Barbara
California
93105
United States
SoCal Diabetes
Torrance
California
90505
United States
Diablo Clinical Research
Walnut Creek
California
94598
United States
Barbara Davis Center
Aurora
Colorado
80045
United States
University of South Florida Diabetes Center
Tampa
Florida
33612
United States
Atlanta Diabetes Associates
Atlanta
Georgia
30318
United States
Endocrine Research Solutions
Roswell
Georgia
30076
United States
Rocky Mountain Diabetes
Idaho Falls
Idaho
93404
United States
Indiana University Health Riley Hospital for Children
Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult
Hanover
30173
Germany
A.S.S.T. Spedali Civili
Brescia
25028
Italy
New Zealand Clinical Research
Christchurch
8011
New Zealand
Dunedin Public Hospital
Dunedin
9016
New Zealand
Hospital Universitario Virgen del RocÃo
Seville
Spain
Dept Internal Medicine, Örebro University Hospital
Örebro
SE-70185
Sweden
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge
United Kingdom
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
FG002
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
FG003
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
FG004
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
FG005
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
FG000150 subjects
FG001148 subjects
FG002126 subjects
FG003122 subjects
FG004164 subjects
FG005160 subjects
COMPLETED
FG000140 subjects
FG001138 subjects
FG002117 subjects
FG003109 subjects
FG004146 subjects
FG005146 subjects
NOT COMPLETED
FG00010 subjects
FG00110 subjects
FG0029 subjects
FG00313 subjects
FG00418 subjects
FG00514 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG0043 subjects
FG0053 subjects
Withdrawal by Subject
FG0007 subjects
FG0014 subjects
FG0024 subjects
FG00311 subjects
FG004
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Continuation Period
Type
Comment
Milestone Data
STARTED
FG000140 subjects
FG001138 subjects
FG002117 subjects
FG003109 subjects
FG004146 subjects
FG005146 subjects
COMPLETED
FG000134 subjects
FG001127 subjects
FG002110 subjects
FG00399 subjects
FG004
NOT COMPLETED
FG0006 subjects
FG00111 subjects
FG0027 subjects
FG00310 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG003
All Subjects Entered the Study Period
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
BG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
BG002
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
BG003
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
BG004
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
BG005
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000150
BG001148
BG002126
BG003122
BG004164
BG005160
BG006870
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
BG00040.0± 19.8
BG00135.1± 18.1
BG00233.6± 19.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00071
BG00190
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG0014
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
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1C > 8%
Study period: 298 subjects in CSII cohort. 147 subjects have available measurements in the baseline A1C > 8% group.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG00074
OG00173
Title
Denominators
Categories
Title
Measurements
OG000-1.6± 1.3
OG001-0.8± 0.9
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
Mean Difference (Final Values)
-0.8
1-Sided
97.5
-0.4
Superiority
Test of Treatment Effect on Change in A1C with Multiple Imputation
Primary
CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Study period: 298 subjects in CSII cohort. 129 subjects have available measurements in the baseline A1C ≤ 8% group.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Primary
MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c > 8%
Study period: 248 subjects in MDI cohort. 94 subjects have available measurements in the baseline A1C > 8% group.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Primary
MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Study period: 248 subjects in MDI cohort. 120 subjects have available measurements in the baseline A1C ≤ 8% group.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Primary
SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c > 8%
Study period: 324 subjects in SAP cohort. 108 subjects have available measurements in the baseline A1C > 8% group.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Primary
SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Study period: 324 subjects in SAP cohort. 177 subjects have available measurements in the baseline A1c ≤ 8% group.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
Study period: 298 subjects in CSII cohort. 136 subjects have available measurements in the baseline A1c > 8% group.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Secondary
CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Study period: 298 subjects in CSII cohort. 131 subjects have available measurements in the baseline A1c ≤ 8% group.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Study period: 298 subjects in CSII cohort. 264 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Secondary
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Study period: 298 subjects in CSII cohort. 264 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Study period: 298 subjects in CSII cohort. 265 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Study period: 298 subjects in CSII cohort. 265 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Secondary
CSII Cohort: Change in A1C for All Subjects
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Study period: 298 subjects in CSII cohort. 278 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
Study period: 248 subjects in MDI cohort. 88 subjects have available measurements in the baseline A1C > 8% group.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Secondary
MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Study period: 248 subjects in MDI cohort. 130 subjects have available measurements in the baseline A1C ≤ 8% group.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Study period: 248 subjects in MDI cohort. 206 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Secondary
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Study period: 248 subjects in MDI cohort. 206 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Study period: 248 subjects in MDI cohort. 208 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Study period: 248 subjects in MDI cohort. 208 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
OG000
Secondary
MDI Cohort: Change in A1C for All Subjects
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Study period: 248 subjects in MDI cohort. 224 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
Study period: 324 subjects in SAP cohort. 106 subjects have available measurements in the A1C > 8% group.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Study period: 324 subjects in SAP cohort. 184 subjects have available measurements in the baseline A1c ≤ 8% group.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of Time
6 months study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Secondary
SAP Cohort: Change in A1C for All Subjects
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Study period: 324 subjects in SAP cohort. 292 subjects have available measurements.
Posted
Mean
Standard Deviation
Percentage of HbA1c
Baseline and end of 6-month study period
ID
Title
Description
OG000
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
OG001
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
Units
Counts
Participants
Time Frame
6 months of Study Period, 6 months of Continuation Period
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
CSII Cohort: Treatment Arm Study Period
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
0
150
1
150
80
150
EG001
CSII Cohort: Control Arm Study Period
In the study period, subjects used the MiniMed pump without CGM.
0
148
4
148
86
148
EG002
MDI Cohort: Treatment Arm Study Period
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
0
126
3
126
72
126
EG003
MDI Cohort: Control Arm Study Period
In the study period, subjects continued to use MDI.
0
122
2
122
77
122
EG004
SAP Cohort: Treatment Arm Study Period
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
0
164
4
164
94
164
EG005
SAP Cohort: Control Arm Study Period
In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode).
0
160
6
160
101
160
EG006
All Patients: Continuation Period
In the continuation period, all subjects were using the Hybrid Closed Loop system.
0
796
26
796
395
796
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG0030 events0 affected122 at risk
EG0040 events0 affected164 at risk
EG0050 events0 affected160 at risk
EG0061 events1 affected796 at risk
Acute sinusitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Appendicitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cellulitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Depression
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Food allergy
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Influenza
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site cellulitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Metastatic squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pneumonia
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Postoperative abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Squamous cell carcinoma of the oral cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Thalamic infarction
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vaginal cancer stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG0030 events0 affected122 at risk
EG0040 events0 affected164 at risk
EG0050 events0 affected160 at risk
EG0062 events2 affected796 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Abscess jaw
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Abscess limb
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Acetonaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Adverse drug reaction
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Alcoholism
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Appendicitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Artificial crown procedure
Surgical and medical procedures
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Astigmatism
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Asymptomatic COVID-19
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Atrophic vulvovaginitis
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Autoimmune disorder
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Biopsy skin
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blepharitis
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blood calcium abnormal
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blood ketone body increased
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blood pressure increased
Investigations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Blood pressure increased
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Body tinea
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bronchitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
COVID-19
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Calcinosis
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Candida infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cardiac murmur
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cardiac stress test abnormal
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cataract
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Catheter site abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cellulitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Chalazion
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Chest pain
General disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Chronic spontaneous urticaria
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Coeliac disease
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Conjunctival cyst
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0003 events3 affected150 at risk
EG0010 events0 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0014 events4 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Croup infectious
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cystitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Deafness bilateral
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Degenerative bone disease
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dental implantation
Surgical and medical procedures
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Depression
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0013 events3 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0011 events1 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Dermoid cyst
Congenital, familial and genetic disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Device breakage
Product Issues
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0012 events2 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Diplopia
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dizziness
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dry eye
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ear infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ear lobe infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Epididymitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Essential hypertension
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Essential tremor
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye allergy
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye infection bacterial
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye irritation
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye pain
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Eye ulcer
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Fatigue
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Folliculitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Food allergy
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0002 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Foreign body in reproductive tract
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Fractured coccyx
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Fungal infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0015 events5 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gastrointestinal disorder
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gingival recession
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gluten sensitivity
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Haematoma
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Headache
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0024 events2 affected126 at risk
EG003
Heat exhaustion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Herpes zoster cutaneous disseminated
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hordeolum
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Hunger
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hyalosis asteroid
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG00013 events11 affected150 at risk
EG00140 events24 affected148 at risk
EG00222 events17 affected126 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypertension
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0015 events4 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Impetigo
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infected cyst
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Influenza
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0005 events5 affected150 at risk
EG0014 events3 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Influenza like illness
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Infusion site abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site bruising
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site cellulitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site cyst
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site erythema
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site haematoma
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site haemorrhage
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site inflammation
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site pain
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site rash
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Infusion site reaction
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Injection site cellulitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Injection site pain
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Injection site swelling
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intersection syndrome
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Intra-uterine contraceptive device insertion
Surgical and medical procedures
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Investigation
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Joint instability
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ketosis
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Large intestine benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Laryngitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Lenticular opacities
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Lentigo
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Lipohypertrophy
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Localised infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Lyme disease
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Major depression
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Malaise
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Mallet finger
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site bruise
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0024 events3 affected126 at risk
EG003
Medical device site dermatitis
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Medical device site dryness
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site erosion
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site erythema
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site haematoma
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site haemorrhage
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Medical device site hypersensitivity
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site inflammation
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site injury
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Medical device site irritation
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0024 events4 affected126 at risk
EG003
Medical device site laceration
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site pain
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Medical device site pruritus
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Medical device site rash
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0024 events2 affected126 at risk
EG003
Medical device site reaction
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Medical device site swelling
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Medical device site vesicles
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Meibomian gland dysfunction
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Migraine
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0013 events3 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Mite allergy
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Mitral valve disease
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Muscle contusion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Myopia
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Myringitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG00011 events9 affected150 at risk
EG00113 events10 affected148 at risk
EG0027 events7 affected126 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Nerve injury
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Non-proliferative retinopathy
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Norovirus infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Oedema peripheral
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Omphalitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Oral herpes
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Osteomyelitis acute
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Otitis externa
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Otitis media
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0011 events1 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pain
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0011 events1 affected148 at risk
EG0022 events2 affected126 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Palpitations
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Paronychia
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Patellofemoral pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Perianal cyst
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Peripheral swelling
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pertussis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Photodermatosis
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Photopsia
Eye disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pinguecula
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pneumonia
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0003 events3 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Postoperative adhesion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Presyncope
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Psychological factor affecting medical condition
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Pyrexia
General disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0025 events4 affected126 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG00010 events10 affected150 at risk
EG0015 events5 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Respiratory alkalosis
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0004 events3 affected150 at risk
EG0014 events3 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Retinal disorder
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Retinal tear
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Retinopathy proliferative
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Rhinitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sciatica
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0023 events3 affected126 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Seizure
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sever's disease
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sinusitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0005 events5 affected150 at risk
EG0013 events3 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Skin infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0004 events4 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Snoring
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Social anxiety disorder
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Somnolence
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Spinal segmental dysfunction
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Stress
Psychiatric disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Syncope
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tendon sheath incision
Surgical and medical procedures
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tension headache
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Thyroid disorder
Endocrine disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tinea infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Tooth infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Tractional retinal detachment
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Ulnocarpal abutment syndrome
Musculoskeletal and connective tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Upper respiratory tract congestion
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0007 events6 affected150 at risk
EG0016 events6 affected148 at risk
EG0025 events4 affected126 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0002 events2 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0006 events4 affected150 at risk
EG0011 events1 affected148 at risk
EG0022 events1 affected126 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
VIth nerve paralysis
Nervous system disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Vaccination site pain
General disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Varicose vein
Vascular disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Viral infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0004 events3 affected150 at risk
EG0011 events1 affected148 at risk
EG0026 events5 affected126 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Viral sinusitis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vision blurred
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Visual impairment
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vitamin B complex deficiency
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vitamin D decreased
Investigations
MedDRA24.0
Systematic Assessment
EG0001 events1 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA24.0
Systematic Assessment
EG0003 events3 affected150 at risk
EG0010 events0 affected148 at risk
EG0029 events8 affected126 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0012 events2 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Weight increased
Investigations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Wisdom teeth removal
Surgical and medical procedures
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0021 events1 affected126 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Wound infection
Infections and infestations
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0011 events1 affected148 at risk
EG0020 events0 affected126 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA24.0
Systematic Assessment
EG0000 events0 affected150 at risk
EG0010 events0 affected148 at risk
EG0020 events0 affected126 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
PI agrees not to publish until 12 months from trial completion or until sponsor publishes multi-center results, whichever occurs first. In either case, sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period more than 60 days but less than or equal to 180 days from the date that the communication is submitted to sponsor for review. Sponsor cannot require changes to the communication and cannot extend the embargo.