Long-Term Safety Evaluation of Dupilumab in Patients With... | NCT02134028 | Trialant
NCT02134028
Sponsor
Sanofi
Status
Completed
Last Update Posted
Mar 28, 2022Actual
Enrollment
2,282Actual
Phase
Phase 3
Conditions
Asthma
Interventions
Dupilumab
Countries
United States
Argentina
Australia
Belgium
Brazil
Canada
Chile
Colombia
Denmark
France
Germany
Hungary
Israel
Italy
Japan
Mexico
Netherlands
Poland
Romania
Russia
South Africa
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02134028
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
LTS12551
Secondary IDs
ID
Type
Description
Link
2013-003856-19
EudraCT Number
U1111-1117-6745
Other Identifier
UTN
Brief Title
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Official Title
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Mar 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 5, 2014Actual
Primary Completion Date
Oct 11, 2019Actual
Completion Date
Oct 11, 2019Actual
First Submitted Date
Apr 30, 2014
First Submission Date that Met QC Criteria
May 6, 2014
First Posted Date
May 8, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 5, 2020
Results First Submitted that Met QC Criteria
Oct 28, 2020
Results First Posted Date
Nov 2, 2020Actual
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
Mar 21, 2022
Last Update Posted Date
Mar 28, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Name
Class
Regeneron Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary Objective:
To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).
Secondary Objectives:
To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.
To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:
Systemic exposure
Anti-drug antibodies
Biomarkers
Detailed Description
A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval.
Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Conditions Module
Conditions
Asthma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,282Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
dupilumab treatment
Experimental
For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1* Dose every 2 weeks added to current controller medications.
For participants coming from other studies: dupilumab 1 * Dose SC every 2 weeks added to current controller medications.
Drug: Dupilumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dupilumab
Drug
Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
dupilumab treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product [IMP] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg.
TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.
Exclusion criteria:
- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.
The above information was not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Pavord ID, Wechsler ME, Busse WW, Domingo C, Xia C, Gall R, Pandit-Abid N, Jacob-Nara JA, Radwan A, Rowe PJ, Deniz Y. Dupilumab efficacy in patients with type 2 asthma and early Feno level reductions. J Allergy Clin Immunol Glob. 2025 Apr 15;4(3):100474. doi: 10.1016/j.jacig.2025.100474. eCollection 2025 Aug.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The Total study duration was maximum of 108 weeks for participants enrolled prior to amendment 4 approval and a maximum of 60 weeks for participants enrolled after amendment 4. Following amendment 4 (dated 31 Oct 2016) open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Recruitment Details
Study was initiated at 365 sites in 27 countries. Participants who successfully completed treatment in studies DRI12544 (NCT01854047),EFC13579 (NCT02414854),EFC13691 (NCT02528214) and PDY14192 (NCT02573233) were eligible to continue their treatment in this extension study LTS12551. Total of 2282 participants were enrolled and treated in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 milligram (mg) on Day 1 followed by a subcutaneous (SC) dose of dupilumab 300 mg every 2 weeks (q2w) for 96 weeks in combination with inhaled corticosteroid (ICS) therapy/long-acting beta-agonist (LABA) therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Participants who completed studies DRI12544, PDY14192, EFC13579, and EFC13691.
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
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
Oct 31, 2016
Oct 4, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
SAR231893
REGN668
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Criteria for potentially clinically significant abnormalities:
TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Number of Severe Exacerbation Events
Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Annualized Event Rate Per Participant-Years for Severe Exacerbation
The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Weeks 24, and 48 of this extension study
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 mean total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
At Weeks 24, and 48 of this extension study
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Weeks 24, and 48 of this extension study
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired). Higher scores indicated better quality of life.
At Weeks 24, and 48 of this extension study
Serum Concentrations of Dupilumab Over Time Till Week 96
For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.
Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Percentage of Participants With Antidrug Antibodies (ADA) Response
ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to > 10,000", where low titer (< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (> 10,000).
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
For this analysis, baseline was defined as respective parent study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime awakenings, 2=woke up once because of asthma (including early awakening), 3=woke up several times because of asthma (including early awakening), 4=bad night, awake most of the night because of asthma; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48, and Week 96 of this extension study
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.
Baseline of parent study, Weeks 48 and 96 of this extension study
Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.
Weeks 48 and 96 of this extension study
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.
Weeks 48, and 96 of this extension study
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.
Baseline of parent study, Week 48 and Week 96 of this extension study
Gilbert
Arizona
85234
United States
Investigational Site Number 840087
Scottsdale
Arizona
85251
United States
Investigational Site Number 840402
Tucson
Arizona
85724
United States
Investigational Site Number 840132
Little Rock
Arkansas
72209
United States
Investigational Site Number 840109
Bakersfield
California
93301
United States
Investigational Site Number 840045
Long Beach
California
90720
United States
Investigational Site Number 840019
Los Angeles
California
90025
United States
Investigational Site Number 840029
Los Angeles
California
90025
United States
Investigational Site Number 840022
Los Angeles
California
90048
United States
Investigational Site Number 840044
Newport Beach
California
92663
United States
Investigational Site Number 840041
North Hollywood
California
91606
United States
Investigational Site Number 840014
Rolling Hills Estates
California
90274
United States
Investigational Site Number 840121
San Jose
California
95117
United States
Investigational Site Number 840040
Colorado Springs
Colorado
80907
United States
Investigational Site Number 840403
Denver
Colorado
80206
United States
Investigational Site Number 840006
Denver
Colorado
80230
United States
Investigational Site Number 840024
Denver
Colorado
80230
United States
Investigational Site Number 840130
Denver
Colorado
80246
United States
Investigational Site Number 840902
New Haven
Connecticut
06510
United States
Investigational Site Number 840137
Aventura
Florida
33180
United States
Investigational Site Number 840071
Gainesville
Florida
32607
United States
Investigational Site Number 840115
Ocoee
Florida
34761
United States
Investigational Site Number 840055
Sarasota
Florida
34239
United States
Investigational Site Number 840079
Twin Falls
Idaho
83301
United States
Investigational Site Number 840101
Chicago
Illinois
60611
United States
Investigational Site Number 840032
Fort Mitchell
Kentucky
41017
United States
Investigational Site Number 840017
Louisville
Kentucky
40223-5440
United States
Investigational Site Number 840030
Owensboro
Kentucky
42301
United States
Investigational Site Number 840064
Bangor
Maine
04401
United States
Investigational Site Number 840052
Chevy Chase
Maryland
20815
United States
Investigational Site Number 840073
Gaithersburg
Maryland
20878
United States
Investigational Site Number 840080
Owings Mills
Maryland
21117
United States
Investigational Site Number 840401
Boston
Massachusetts
02115
United States
Investigational Site Number 840018
Minneapolis
Minnesota
55402
United States
Investigational Site Number 840002
St Louis
Missouri
63110
United States
Investigational Site Number 840102
St Louis
Missouri
63141
United States
Investigational Site Number 840093
St Louis
Missouri
United States
Investigational Site Number 840037
Missoula
Montana
59808
United States
Investigational Site Number 840078
Omaha
Nebraska
68124
United States
Investigational Site Number 840004
Papillion
Nebraska
27103
United States
Investigational Site Number 840111
Brick
New Jersey
08723
United States
Investigational Site Number 840068
Ocean City
New Jersey
07712
United States
Investigational Site Number 840011
Princeton
New Jersey
08540
United States
Investigational Site Number 840065
New York
New York
10029
United States
Investigational Site Number 840126
Charlotte
North Carolina
28226
United States
Investigational Site Number 840083
Charlotte
North Carolina
28277
United States
Investigational Site Number 840108
Durham
North Carolina
27705
United States
Investigational Site Number 840107
Greensboro
North Carolina
27401
United States
Investigational Site Number 840907
High Point
North Carolina
27262
United States
Investigational Site Number 840404
Winston-Salem
North Carolina
27157-1071
United States
Investigational Site Number 840015
Cincinnati
Ohio
45236
United States
Investigational Site Number 840146
Cincinnati
Ohio
45241
United States
Investigational Site Number 840049
Middleburg Heights
Ohio
44130
United States
Investigational Site Number 840942
Toledo
Ohio
43617
United States
Investigational Site Number 840112
Edmond
Oklahoma
73034
United States
Investigational Site Number 840104
Tulsa
Oklahoma
74136
United States
Investigational Site Number 840034
Medford
Oregon
97504
United States
Investigational Site Number 840031
Portland
Oregon
97223
United States
Investigational Site Number 840046
Bethlehem
Pennsylvania
18020
United States
Investigational Site Number 840085
Hershey
Pennsylvania
17033
United States
Investigational Site Number 840067
Philadelphia
Pennsylvania
19140
United States
Investigational Site Number 840928
Pittsburgh
Pennsylvania
15213
United States
Investigational Site Number 840091
Pittsburgh
Pennsylvania
15241
United States
Investigational Site Number 840082
Charleston
South Carolina
29407
United States
Investigational Site Number 840117
Greenville
South Carolina
29607
United States
Investigational Site Number 840021
Spartanburg
South Carolina
29303
United States
Investigational Site Number 840062
Amarillo
Texas
79106
United States
Investigational Site Number 840038
Boerne
Texas
78006
United States
Investigational Site Number 840124
Cypress
Texas
77429
United States
Investigational Site Number 840023
Dallas
Texas
75231
United States
Investigational Site Number 840923
El Paso
Texas
79903
United States
Investigational Site Number 840922
Fort Worth
Texas
76109
United States
Investigational Site Number 840027
Fort Worth
Texas
76244
United States
Investigational Site Number 840070
McKinney
Texas
75069
United States
Investigational Site Number 840118
Plano
Texas
75093
United States
Investigational Site Number 840008
San Antonio
Texas
78229
United States
Investigational Site Number 840035
Draper
Utah
84020
United States
Investigational Site Number 840077
Murray
Utah
84107
United States
Investigational Site Number 840057
South Burlington
Vermont
05403
United States
Investigational Site Number 840059
Fairfax
Virginia
22030
United States
Investigational Site Number 840951
Bellingham
Washington
98225
United States
Investigational Site Number 032096
Bahía Blanca
B8000JRB
Argentina
Investigational Site Number 032004
Buenos Aires
B6500BWQ
Argentina
Investigational Site Number 032003
Buenos Aires
C1121ABE
Argentina
Investigational Site Number 032011
Caba
1120
Argentina
Investigational Site Number 032097
Caba
C1414AIF
Argentina
Investigational Site Number 032001
Caba
C1425BEN
Argentina
Investigational Site Number 032010
Caba
C1425FVH
Argentina
Investigational Site Number 032091
Caba
C1426ABP
Argentina
Investigational Site Number 032095
Capital Federal
C1425DUC
Argentina
Investigational Site Number 032002
La Plata
B1900BNN
Argentina
Investigational Site Number 032006
Rosario
S2000BRH
Argentina
Investigational Site Number 032007
Rosario
S2000DBS
Argentina
Investigational Site Number 032005
Rosario
S2000JKR
Argentina
Investigational Site Number 032012
San Miguel de Tucumán
T4000CHE
Argentina
Investigational Site Number 032009
San Miguel de Tucumán
T4000IAR
Argentina
Investigational Site Number 036004
Adelaide
5000
Australia
Investigational Site Number 036005
Campbelltown
2560
Australia
Investigational Site Number 036001
Clayton
3168
Australia
Investigational Site Number 036008
Frankston
3199
Australia
Investigational Site Number 036093
Murdoch
6150
Australia
Investigational Site Number 036003
Nedlands
6009
Australia
Investigational Site Number 036094
Parkville
3050
Australia
Investigational Site Number 036009
Prahran
3004
Australia
Investigational Site Number 036006
Woolloongabba
4102
Australia
Investigational Site Number 056002
Brussels
1020
Belgium
Investigational Site Number 056003
Ghent
9000
Belgium
Investigational Site Number 056001
Leuven
3000
Belgium
Investigational Site Number 076009
Florianópolis
88040-970
Brazil
Investigational Site Number 076007
Porto Alegre
90020-090
Brazil
Investigational Site Number 076001
Porto Alegre
90610-000
Brazil
Investigational Site Number 076003
Salvador
41940-455
Brazil
Investigational Site Number 076013
São Bernardo do Campo
09715-090
Brazil
Investigational Site Number 076012
São Paulo
04266-010
Brazil
Investigational Site Number 076006
São Paulo
05437-000
Brazil
Investigational Site Number 076002
Sorocaba
18040-425
Brazil
Investigational Site Number 124019
Burlington
L7N 3V2
Canada
Investigational Site Number 124009
Calgary
T2N 4Z6
Canada
Investigational Site Number 124016
Hamilton
L8N 4A6
Canada
Investigational Site Number 124003
Mississauga
L5A 3V4
Canada
Investigational Site Number 124001
Montreal
H2X 3E4
Canada
Investigational Site Number 124012
Montreal
H4A 3J1
Canada
Investigational Site Number 124010
Montreal
H4J 1C5
Canada
Investigational Site Number 124013
Ottawa
K1G 6C6
Canada
Investigational Site Number 124018
Québec
G1V 4G5
Canada
Investigational Site Number 124014
Québec
G1V 4W2
Canada
Investigational Site Number 124008
Sherbrooke
J1H 5N4
Canada
Investigational Site Number 124015
Toronto
M5G 1E2
Canada
Investigational Site Number 124002
Toronto
M5T 3A9
Canada
Investigational Site Number 124007
Trois-Rivières
G8T 7A1
Canada
Investigational Site Number 124006
Vancouver
V5Z 1M9
Canada
Investigational Site Number 124017
Vancouver
V6Z 1Y6
Canada
Investigational Site Number 152007
Quillota
2260877
Chile
Investigational Site Number 152024
Santiago
7500588
Chile
Investigational Site Number 152005
Santiago
7500692
Chile
Investigational Site Number 152014
Santiago
7500698
Chile
Investigational Site Number 152011
Santiago
7500710
Chile
Investigational Site Number 152018
Santiago
8207257
Chile
Investigational Site Number 152002
Santiago
8380456
Chile
Investigational Site Number 152013
Santiago
8910131
Chile
Investigational Site Number 152008
Talca
3460001
Chile
Investigational Site Number 152004
Talca
Chile
Investigational Site Number 152023
Talcahuano
Chile
Investigational Site Number 152010
Valdivia
5090145
Chile
Investigational Site Number 152003
Viña del Mar
2520024
Chile
Investigational Site Number 152021
Viña del Mar
2520594
Chile
Investigational Site Number 170001
Bogotá
110121
Colombia
Investigational Site Number 170002
Bogotá
110231
Colombia
Investigational Site Number 208002
Hvidovre
2650
Denmark
Investigational Site Number 208001
København NV
2400
Denmark
Investigational Site Number 250009
Brest
29609
France
Investigational Site Number 250004
La Tronche
38700
France
Investigational Site Number 250010
Lille
59037
France
Investigational Site Number 250013
Lille
59037
France
Investigational Site Number 250006
Lyon
69317
France
Investigational Site Number 250001
Marseille
13015
France
Investigational Site Number 250002
Montpellier
34295
France
Investigational Site Number 250005
Nantes
44033
France
Investigational Site Number 250007
Nîmes
30029
France
Investigational Site Number 250008
Strasbourg
67091
France
Investigational Site Number 250014
Vandœuvre-lès-Nancy
54511
France
Investigational Site Number 276006
Berlin
10787
Germany
Investigational Site Number 276003
Bochum
44789
Germany
Investigational Site Number 276010
Frankfurt am Main
60596
Germany
Investigational Site Number 276011
Großhansdorf
22927
Germany
Investigational Site Number 276009
Koblenz
56068
Germany
Investigational Site Number 276005
Rüdersdorf Bei Berlin
15562
Germany
Investigational Site Number 348301
Balassagyarmat
2660
Hungary
Investigational Site Number 348303
Edelény
3780
Hungary
Investigational Site Number 348003
Gödöllö
2100
Hungary
Investigational Site Number 376003
Haifa
34362
Israel
Investigational Site Number 376001
Kfar Saba
44281
Israel
Investigational Site Number 376005
Petah Tikva
49100
Israel
Investigational Site Number 376002
Rehovot
76100
Israel
Investigational Site Number 380010
Ancona
60126
Italy
Investigational Site Number 380009
Catania
95123
Italy
Investigational Site Number 380004
Ferrara
44124
Italy
Investigational Site Number 380008
Foggia
71100
Italy
Investigational Site Number 380002
Genova
16132
Italy
Investigational Site Number 380003
Modena
41124
Italy
Investigational Site Number 380007
Padova
35128
Italy
Investigational Site Number 380099
Palermo
90146
Italy
Investigational Site Number 380001
Pisa
56100
Italy
Investigational Site Number 392185
Akashi-Shi
Japan
Investigational Site Number 392009
Asahi-Shi
Japan
Investigational Site Number 392037
Chiyoda-Ku
Japan
Investigational Site Number 392002
Chūōku
Japan
Investigational Site Number 392007
Chūōku
Japan
Investigational Site Number 392112
Chūōku
Japan
Investigational Site Number 392012
Edogawa-Ku
Japan
Investigational Site Number 392137
Fukuoka
Japan
Investigational Site Number 392021
Fukuyama-Shi
Japan
Investigational Site Number 392030
Habikino-Shi
Japan
Investigational Site Number 392004
Himeji-Shi
Japan
Investigational Site Number 392032
Hirakata-Shi
Japan
Investigational Site Number 392108
Hiroshima
Japan
Investigational Site Number 392158
Hiroshima
Japan
Investigational Site Number 392013
Iizuka-Shi
Japan
Investigational Site Number 392042
Isesaki-Shi
Japan
Investigational Site Number 392023
Kanazawa
Japan
Investigational Site Number 392142
Kasuga-Shi
Japan
Investigational Site Number 392119
Kishiwada-Shi
Japan
Investigational Site Number 392025
Kobe
Japan
Investigational Site Number 392162
Kobe
Japan
Investigational Site Number 392040
Kodaira-Shi
Japan
Investigational Site Number 392044
Kokubunji-Shi
Japan
Investigational Site Number 392131
Koushi-Shi
Japan
Investigational Site Number 392010
Kurashiki-Shi
Japan
Investigational Site Number 392036
Kyoto
Japan
Investigational Site Number 392153
Kyoto
Japan
Investigational Site Number 392133
Machida-Shi
Japan
Investigational Site Number 392135
Matsuyama
Japan
Investigational Site Number 392122
Minatoku
Japan
Investigational Site Number 392144
Minatoku
Japan
Investigational Site Number 392106
Mizunami-Shi
Japan
Investigational Site Number 392164
Muroran-Shi
Japan
Investigational Site Number 392163
Nagoya
Japan
Investigational Site Number 392020
Naka-Gun
Japan
Investigational Site Number 392005
Naruto-Shi
Japan
Investigational Site Number 392187
Obihiro-Shi
Japan
Investigational Site Number 392177
Ome-Shi
Japan
Investigational Site Number 392152
Osaka Sayama-Shi
Japan
Investigational Site Number 392155
Osaka Sayama-Shi
Japan
Investigational Site Number 392170
Osaki-Shi
Japan
Investigational Site Number 392043
Ota-Shi
Japan
Investigational Site Number 392127
Ōta-ku
Japan
Investigational Site Number 392169
Sagamihara-Shi
Japan
Investigational Site Number 392011
Sakaide-Shi
Japan
Investigational Site Number 392024
Sakaishi
Japan
Investigational Site Number 392008
Sapporo
Japan
Investigational Site Number 392034
Sapporo
Japan
Investigational Site Number 392038
Setagaya-Ku
Japan
Investigational Site Number 392179
Seto-Shi
Japan
Investigational Site Number 392186
Shibuya-Ku
Japan
Investigational Site Number 392167
Shinagawa-Ku
Japan
Investigational Site Number 392130
Shinjuku-Ku
Japan
Investigational Site Number 392165
Sumida-Ku
Japan
Investigational Site Number 392146
Tachikawa-Shi
Japan
Investigational Site Number 392173
Tachikawa-Shi
Japan
Investigational Site Number 392006
Tomakomai-Shi
Japan
Investigational Site Number 392029
Tsu
Japan
Investigational Site Number 392168
Uozu-Shi
Japan
Investigational Site Number 392132
Urasoe-Shi
Japan
Investigational Site Number 392045
Uruma
Japan
Investigational Site Number 392014
Yokohama
Japan
Investigational Site Number 484013
Chihuahua City
31020
Mexico
Investigational Site Number 484006
Chihuahua City
31200
Mexico
Investigational Site Number 484014
Cuautitlán Izcalli
54769
Mexico
Investigational Site Number 484005
Distrito Federal
07760
Mexico
Investigational Site Number 484008
Durango
34080
Mexico
Investigational Site Number 484001
Guadalajara
44100
Mexico
Investigational Site Number 484004
Mexico City
64718
Mexico
Investigational Site Number 484010
México
06700
Mexico
Investigational Site Number 484003
Monterrey
64460
Mexico
Investigational Site Number 484007
Monterrey
66465
Mexico
Investigational Site Number 484012
San Juan del Río
76800
Mexico
Investigational Site Number 484011
Veracruz
91910
Mexico
Investigational Site Number 528001
Arnhem
6815 AD
Netherlands
Investigational Site Number 528002
Dordrecht
3318 AT
Netherlands
Investigational Site Number 616006
Bialystok
15-010
Poland
Investigational Site Number 616004
Gdansk
80-405
Poland
Investigational Site Number 616003
Gdansk
80-952
Poland
Investigational Site Number 616007
Krakow
31-159
Poland
Investigational Site Number 616097
Krakow
31-159
Poland
Investigational Site Number 616001
Lodz
90-141
Poland
Investigational Site Number 616005
Lodz
90-153
Poland
Investigational Site Number 616009
Lodz
90-329
Poland
Investigational Site Number 616096
Poznan
60-693
Poland
Investigational Site Number 616098
Strzelce Opolskie
47-100
Poland
Investigational Site Number 616008
Warsaw
00-013
Poland
Investigational Site Number 616010
Warsaw
04-141
Poland
Investigational Site Number 616011
Żnin
88-400
Poland
Investigational Site Number 642104
Bucharest
011461
Romania
Investigational Site Number 642103
Bucharest
050159
Romania
Investigational Site Number 642102
Cluj-Napoca
400162
Romania
Investigational Site Number 642107
Cluj-Napoca
400371
Romania
Investigational Site Number 642105
Timișoara
300310
Romania
Investigational Site Number 642106
Timișoara
300310
Romania
Investigational Site Number 643096
Moscow
105077
Russia
Investigational Site Number 643002
Moscow
109240
Russia
Investigational Site Number 643005
Moscow
115280
Russia
Investigational Site Number 643007
Moscow
117574
Russia
Investigational Site Number 643012
Moscow
123182
Russia
Investigational Site Number 643001
Moscow
125315
Russia
Investigational Site Number 643006
Novosibirsk
630091
Russia
Investigational Site Number 643091
Ryazan
390039
Russia
Investigational Site Number 643099
Saint Petersburg
193231
Russia
Investigational Site Number 643011
Saint Petersburg
194223
Russia
Investigational Site Number 643010
Saint Petersburg
194354
Russia
Investigational Site Number 643009
Saint Petersburg
197022
Russia
Investigational Site Number 643008
Yaroslavl
150003
Russia
Investigational Site Number 643013
Yekaterinburg
620028
Russia
Investigational Site Number 710011
Cape Town
7505
South Africa
Investigational Site Number 710001
Cape Town
7530
South Africa
Investigational Site Number 710091
Cape Town
7700
South Africa
Investigational Site Number 710092
Cape Town
7700
South Africa
Investigational Site Number 710002
Cape Town
7764
South Africa
Investigational Site Number 710003
Cape Town
8000
South Africa
Investigational Site Number 710006
Durban
4071
South Africa
Investigational Site Number 710007
Pretoria
0087
South Africa
Investigational Site Number 710009
Winnie Mandela
9400
South Africa
Investigational Site Number 410002
Bucheon-si
14584
South Korea
Investigational Site Number 410003
Cheongju-si
28644
South Korea
Investigational Site Number 410013
Incheon
21565
South Korea
Investigational Site Number 410006
Seoul
03080
South Korea
Investigational Site Number 410008
Seoul
03312
South Korea
Investigational Site Number 410004
Seoul
03722
South Korea
Investigational Site Number 410012
Seoul
04763
South Korea
Investigational Site Number 410005
Seoul
05505
South Korea
Investigational Site Number 410007
Seoul
06351
South Korea
Investigational Site Number 410010
Seoul
06973
South Korea
Investigational Site Number 410011
Seoul
08308
South Korea
Investigational Site Number 410001
Suwon
16499
South Korea
Investigational Site Number 724014
Barcelona
08023
Spain
Investigational Site Number 724002
Barcelona
08035
Spain
Investigational Site Number 724001
Barcelona
08036
Spain
Investigational Site Number 724010
Palma de Mallorca
07120
Spain
Investigational Site Number 724006
Pozuelo de Alarcón
28223
Spain
Investigational Site Number 724003
Sabadell
08208
Spain
Investigational Site Number 724007
Sant Boi de Llobregat
08830
Spain
Investigational Site Number 724096
Santiago de Compostela
15706
Spain
Investigational Site Number 724008
Seville
41071
Spain
Investigational Site Number 724097
Valencia
46017
Spain
Investigational Site Number 158008
New Taipei City
23561
Taiwan
Investigational Site Number 158007
Taichung
40447
Taiwan
Investigational Site Number 158009
Taipei
11031
Taiwan
Investigational Site Number 792002
Ankara
06100
Turkey (Türkiye)
Investigational Site Number 792098
Ankara
06100
Turkey (Türkiye)
Investigational Site Number 792008
Bursa
16059
Turkey (Türkiye)
Investigational Site Number 792007
Istanbul
34020
Turkey (Türkiye)
Investigational Site Number 792001
Istanbul
34098
Turkey (Türkiye)
Investigational Site Number 792004
Istanbul
34098
Turkey (Türkiye)
Investigational Site Number 792003
Istanbul
34844
Turkey (Türkiye)
Investigational Site Number 792005
Izmir
35040
Turkey (Türkiye)
Investigational Site Number 792090
Izmir
35110
Turkey (Türkiye)
Investigational Site Number 792013
Kirikkale
71450
Turkey (Türkiye)
Investigational Site Number 792006
Mersin
33070
Turkey (Türkiye)
Investigational Site Number 792096
Rize
53100
Turkey (Türkiye)
Investigational Site Number 804007
Chernivtsi
58001
Ukraine
Investigational Site Number 804023
Dnipro
49101
Ukraine
Investigational Site Number 804009
Ivano-Frankivsk
76018
Ukraine
Investigational Site Number 804094
Ivano-Frankivsk
76018
Ukraine
Investigational Site Number 804005
Kharkiv
61058
Ukraine
Investigational Site Number 804021
Kharkiv
61093
Ukraine
Investigational Site Number 804001
Kharkiv
61124
Ukraine
Investigational Site Number 804004
Kyiv
03049
Ukraine
Investigational Site Number 804003
Kyiv
03680
Ukraine
Investigational Site Number 804008
Kyiv
03680
Ukraine
Investigational Site Number 804017
Kyiv
03680
Ukraine
Investigational Site Number 804018
Kyiv
03680
Ukraine
Investigational Site Number 804020
Kyiv
03680
Ukraine
Investigational Site Number 804016
Kyiv
04050
Ukraine
Investigational Site Number 804006
Odesa
65025
Ukraine
Investigational Site Number 804002
Poltava
36038
Ukraine
Investigational Site Number 804014
Ternopil
46000
Ukraine
Investigational Site Number 804019
Vinnytsia
21001
Ukraine
Investigational Site Number 804015
Yalta
298603
Ukraine
Investigational Site Number 804022
Zaporizhzhya
69076
Ukraine
Investigational Site Number 804012
Zaporizhzhya
69118
Ukraine
Investigational Site Number 826001
Bradford
BD9 6RJ
United Kingdom
Investigational Site Number 826010
London
W2 1NY
United Kingdom
Investigational Site Number 826009
Oxford
OX3 7LE
United Kingdom
Investigational Site Number 826007
Portsmouth
PO6 3LY
United Kingdom
Investigational Site Number 826006
South Shields
NE34 0PL
United Kingdom
Pavord ID, Rabe KF, Israel E, Szefler SJ, Brusselle G, Pandit-Abid N, Altincatal A, Chen Z, Amin N, Khan AH, Lederer DJ, Zhang Y, Rowe PJ, Deniz Y, Radwan A, Jacob-Nara JA, Busse WW. Dupilumab Induces Long-Term On-Treatment Clinical Remission in Patients With Type 2 Asthma. J Allergy Clin Immunol Pract. 2025 Jan;13(1):132-142. doi: 10.1016/j.jaip.2024.10.009. Epub 2024 Oct 16.
Rhee CK, Park JW, Park HW, Noh H, Msihid J, Cho YS. Long-term Safety and Efficacy of Dupilumab in Patients With Uncontrolled, Moderate-to-Severe Asthma Recruited From Korean Centers: A Subgroup Analysis of the Phase 3 LIBERTY ASTHMA TRAVERSE Trial. Allergy Asthma Immunol Res. 2024 Jul;16(4):372-386. doi: 10.4168/aair.2024.16.4.372.
Maspero JF, Peters AT, Chapman KR, Domingo C, Stewart J, Hardin M, Maroni J, Tawo K, Khokhar FA, Mortensen E, Laws E, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study. J Allergy Clin Immunol Pract. 2024 Apr;12(4):991-997.e6. doi: 10.1016/j.jaip.2023.12.043. Epub 2023 Dec 30.
Peters AT, Sagara H, Corren J, Domingo C, Altincatal A, Soler X, Pandit-Abid N, Crikelair N, Rowe PJ, Jacob-Nara JA, Deniz Y. Impact of dupilumab across seasons in patients with type 2, uncontrolled, moderate-to-severe asthma. Ann Allergy Asthma Immunol. 2024 Apr;132(4):477-484.e4. doi: 10.1016/j.anai.2023.11.021. Epub 2023 Nov 25.
Wechsler ME, Souza-Machado A, Xu C, Mao X, Kapoor U, Khokhar FA, O'Malley JT, Petro CD, Casullo VM, Mannent LP, Rowe PJ, Jacob-Nara JA, Ruddy M, Laws E, Purcell LA, Hardin M. Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines. J Allergy Clin Immunol Glob. 2021 Dec 8;1(1):9-15. doi: 10.1016/j.jacig.2021.12.003. eCollection 2022 Feb.
Pavord ID, Bourdin A, Papi A, Domingo C, Corren J, Altincatal A, Radwan A, Pandit-Abid N, Jacob-Nara JA, Deniz Y, Rowe PJ, Laws E, Lederer DJ, Hardin M. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023 Nov;78(11):2921-2932. doi: 10.1111/all.15792. Epub 2023 Jul 11.
Rabe KF, Pavord ID, Busse WW, Chupp GL, Izuhara K, Altincatal A, Gall R, Pandit-Abid N, Deniz Y, Rowe PJ, Jacob-Nara JA, Radwan A. Dupilumab improves long-term outcomes in patients with uncontrolled, moderate-to-severe GINA-based type 2 asthma, irrespective of allergic status. Allergy. 2023 Aug;78(8):2148-2156. doi: 10.1111/all.15747. Epub 2023 May 21.
Sher LD, Corren J, Pavord ID, Daizadeh N, Altincatal A, Soler X, Djandji M, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Dupilumab long-term efficacy in patients with non-OCS-dependent asthma with and without evidence of allergic asthma. J Asthma. 2023 Sep;60(9):1767-1774. doi: 10.1080/02770903.2023.2185895. Epub 2023 May 31.
Sher LD, Passalacqua G, Taille C, Cohn L, Daizadeh N, Pandit-Abid N, Soler X, Khodzhayev A, Jacob-Nara JA, Deniz Y, Rowe PJ, Nag A, Zhang Y. The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma. Ann Allergy Asthma Immunol. 2023 Mar;130(3):298-304. doi: 10.1016/j.anai.2022.12.002. Epub 2022 Dec 9.
Berger P, Menzies-Gow A, Peters AT, Kuna P, Rabe KF, Altincatal A, Soler X, Pandit-Abid N, Siddiqui S, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-term efficacy of dupilumab in asthma with or without chronic rhinosinusitis and nasal polyps. Ann Allergy Asthma Immunol. 2023 Feb;130(2):215-224. doi: 10.1016/j.anai.2022.11.006. Epub 2022 Nov 7.
Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Msihid J, Djandji M, Ortiz B, Jacob-Nara JA, Deniz Y, Rowe PJ, Ishida M, Arima K. Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study. Allergol Int. 2023 Jan;72(1):89-99. doi: 10.1016/j.alit.2022.07.008. Epub 2022 Sep 13.
Lugogo N, Mohan A. Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics? Chest. 2022 Jul;162(1):4-5. doi: 10.1016/j.chest.2022.04.004. No abstract available.
Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
Sher LD, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, Ortiz B, Mannent LP, Laws E, Ruddy M, Pandit-Abid N, Jacob-Nara JA, Gall R, Rowe PJ, Deniz Y, Lederer DJ, Hardin M. Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial. Chest. 2022 Jul;162(1):46-55. doi: 10.1016/j.chest.2022.01.071. Epub 2022 Feb 22.
Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, Watz H, Castro M, Nenasheva NM, Tohda Y, Langton D, Cardona G, Domingo C, Park HS, Chapman KR, Mao X, Zhang Y, Khan AH, Deniz Y, Rowe PJ, Kapoor U, Khokhar FA, Mannent LP, Ruddy M, Laws E, Amin N, Hardin M. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022 Jan;10(1):11-25. doi: 10.1016/S2213-2600(21)00322-2. Epub 2021 Sep 28.
FG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with oral corticosteroids (OCS) and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
FG000111 subjects
FG001421 subjects
FG002517 subjects
FG0031013 subjects
FG00497 subjects
FG00590 subjects
FG00619 subjects
FG00714 subjects
COMPLETED
FG000102 subjects
FG001379 subjects
FG002465 subjects
FG003908 subjects
FG00483 subjects
FG00576 subjects
FG00615 subjects
FG00711 subjects
NOT COMPLETED
FG0009 subjects
FG00142 subjects
FG00252 subjects
FG003105 subjects
FG00414 subjects
FG00514 subjects
FG0064 subjects
FG0073 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
Poor compliance to protocol
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0037 subjects
FG004
Other unspecified
FG0004 subjects
FG00122 subjects
FG00233 subjects
FG00364 subjects
FG004
Adverse Event
FG0003 subjects
FG00119 subjects
FG00213 subjects
FG00332 subjects
FG004
Analysis was performed on all enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000111
BG001421
BG002517
BG0031013
BG00497
BG00590
BG00619
BG00714
BG0082282
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<18 years
Title
Measurements
BG0000
BG0010
BG00232
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00069
BG001259
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product [IMP] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Analysis was performed on exposed population which included participants who actually received at least 1 dose or part of a dose of the IMP in LTS12551 study.
Posted
Count of Participants
Participants
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG003
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00088
OG001369
OG002414
OG003
Secondary
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg.
TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Count of Participants
Participants
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Criteria for potentially clinically significant abnormalities:
TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Count of Participants
Participants
From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Secondary
Number of Severe Exacerbation Events
Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.
Analysis was performed on exposed population.
Posted
Number
number of events
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Annualized Event Rate Per Participant-Years for Severe Exacerbation
The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
Analysis was performed on exposed population.
Posted
Number
exacerbation per participant-years
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Mean
Standard Deviation
liters
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Mean
Standard Deviation
percent predicted FEV1
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Mean
Standard Deviation
liters
Baseline of parent study, Week 48, and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Mean
Standard Deviation
liters/second
Baseline of parent study, Week 48, and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Mean
Standard Deviation
score on a scale
Baseline of parent study, Weeks 24, and 48 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Secondary
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 mean total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Number
percentage of participants
At Weeks 24, and 48 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed for the participants from Studies DRI12544, EFC13579, and EFC13691 only.
Posted
Mean
Standard Deviation
score on a scale
Baseline of parent study, Weeks 24, and 48 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Secondary
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired). Higher scores indicated better quality of life.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed for the participants from Studies DRI12544, EFC13579, and EFC13691 only.
Posted
Number
percentage of participants
At Weeks 24, and 48 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Secondary
Serum Concentrations of Dupilumab Over Time Till Week 96
For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.
Analysis was performed on Pharmacokinetics (PK) population which consisted of all the participants who had actually received at least one dose or part of a dose of dupilumab in the LTS12551 study, with at least one non-missing and evaluable pre-dose serum concentration value after the first dose of dupilumab in the LTS12551 study.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Percentage of Participants With Antidrug Antibodies (ADA) Response
ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as "30 to > 10,000", where low titer (< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (> 10,000).
Analysis was performed on ADA population which consisted of all participants who had actually received at least one dose or part of a dose of dupilumab in the LTS12551 study, with at least one pre-dose sample that was assayed successfully using the ADA assay after the first dose of dupilumab in the LTS12551 study.
Posted
Number
percentage of participants
From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Secondary
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
For this analysis, baseline was defined as respective parent study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
Posted
Mean
Standard Deviation
10^9 cells/L
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Secondary
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
liters per minute (L/min)
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
L/min
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime awakenings, 2=woke up once because of asthma (including early awakening), 3=woke up several times because of asthma (including early awakening), 4=bad night, awake most of the night because of asthma; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
score on a scale
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Secondary
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
score on a scale
Baseline of parent study, Week 48, and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
inhalations per day
Baseline of parent study, Week 48, and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
nocturnal awakenings
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
Posted
Mean
Standard Deviation
percent change
Baseline of parent study, Weeks 48 and 96 of this extension study
ID
Title
Description
OG000
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
Posted
Number
percentage of participants
Weeks 48 and 96 of this extension study
ID
Title
Description
OG000
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
Posted
Number
percentage of participants
Weeks 48, and 96 of this extension study
ID
Title
Description
OG000
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
score on a scale
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Secondary
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.
Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
Posted
Mean
Standard Deviation
score on a scale
Baseline of parent study, Week 48 and Week 96 of this extension study
ID
Title
Description
OG000
Participants From DRI12544: Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Time Frame
Reported AE and deaths were TEAEs that developed, worsened, or became serious and deaths that occurred during the TEAE period (time from the first dose of dupilumab in LTS12551 up to the last dose of dupilumab plus 14 weeks) (i.e. up to 108 weeks).
Description
Analysis was performed on safety population.
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
Participants From DRI12544 Study Placebo/Dupilumab
Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
0
111
14
111
80
111
EG001
Participants From DRI12544 Study Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
3
421
42
421
323
421
EG002
Participants From EFC13579 Study Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
0
517
48
517
357
517
EG003
Participants From EFC13579 Study Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
1
1,013
106
1,013
666
1,013
EG004
Participants From EFC13691 Study Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
0
97
12
97
56
97
EG005
Participants From EFC13691 Study Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
0
90
10
90
55
90
EG006
Participants From PDY14192 Study Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with CS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
0
19
0
19
18
19
EG007
Participants From PDY14192 Study Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
0
14
4
14
13
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Coronary Syndrome
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG0030 events0 affected1,013 at risk
EG0040 events0 affected97 at risk
EG0051 events1 affected90 at risk
EG0060 events0 affected19 at risk
EG0070 events0 affected14 at risk
Acute Left Ventricular Failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Aortic Valve Incompetence
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0022 events2 affected517 at risk
EG003
Atrioventricular Block Complete
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Odontogenic Cyst
Congenital, familial and genetic disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Goitre
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Angle Closure Glaucoma
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Serous Retinal Detachment
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Abdominal Incarcerated Hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Diaphragmatic Hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Diverticulum Intestinal
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Gastritis Erosive
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Gastroenteritis Eosinophilic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Intra-Abdominal Haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Oesophageal Food Impaction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Retroperitoneum Cyst
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Tooth Impacted
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Injection Site Erythema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Eosinophilic Granulomatosis With Polyangiitis
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Bronchopulmonary Aspergillosis Allergic
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Cervicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Chronic Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Ear Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Herpes Simplex Encephalitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Large Intestine Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Lower Respiratory Tract Infection Bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Mycobacterium Avium Complex Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG0014 events4 affected421 at risk
EG0024 events4 affected517 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Wound Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Chemical Peritonitis
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Incision Site Pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Post Procedural Constipation
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pulmonary Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Diabetic Metabolic Decompensation
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0014 events3 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Adenocarcinoma Gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Adenocarcinoma Of Colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Benign Ovarian Tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Bowen's Disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0022 events2 affected517 at risk
EG003
Colon Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Endometrial Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Fibroadenoma Of Breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Follicular Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Gastric Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Hodgkin's Disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Intraductal Proliferative Breast Lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Juvenile Melanoma Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Large Intestine Benign Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Lung Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Metastases To Central Nervous System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Non-Small Cell Lung Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Osteochondroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Ovarian Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Papillary Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Prostate Cancer Stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Rectal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Squamous Cell Carcinoma Of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0013 events3 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Carotid Artery Disease
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Hypertensive Cerebrovascular Disease
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Idiopathic Intracranial Hypertension
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Neuritis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Optic Neuritis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Parkinson's Disease
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Thalamic Infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Iga Nephropathy
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Endometrial Hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Haemorrhagic Ovarian Cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Vaginal Prolapse
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected111 at risk
EG0012 events2 affected421 at risk
EG00213 events13 affected517 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Nasal Septum Deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Nasal Septum Perforation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Sinusitis Noninfective
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Status Asthmaticus
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Vocal Cord Polyp
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Erythema Nodosum
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Rash Vesicular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Miscarriage Of Partner
Social circumstances
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Aortic Dilatation
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0013 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear Pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0021 events1 affected517 at risk
EG0036 events6 affected1,013 at risk
EG0040 events0 affected97 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected19 at risk
EG0070 events0 affected14 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Dry Eye
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0015 events4 affected421 at risk
EG0022 events2 affected517 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG00113 events12 affected421 at risk
EG00211 events9 affected517 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0015 events5 affected421 at risk
EG0026 events6 affected517 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected111 at risk
EG0016 events6 affected421 at risk
EG0024 events4 affected517 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG00120 events16 affected421 at risk
EG0029 events7 affected517 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0012 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG00114 events13 affected421 at risk
EG00215 events13 affected517 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG00136 events6 affected421 at risk
EG0028 events8 affected517 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG0014 events4 affected421 at risk
EG0025 events5 affected517 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG00112 events10 affected421 at risk
EG0025 events5 affected517 at risk
EG003
Injection Site Bruising
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Injection Site Erythema
General disorders
MedDRA 22.0
Systematic Assessment
EG000102 events26 affected111 at risk
EG001412 events55 affected421 at risk
EG002148 events35 affected517 at risk
EG003
Injection Site Haematoma
General disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected111 at risk
EG0012 events2 affected421 at risk
EG0024 events4 affected517 at risk
EG003
Injection Site Haemorrhage
General disorders
MedDRA 22.0
Systematic Assessment
EG0007 events5 affected111 at risk
EG0015 events5 affected421 at risk
EG0025 events5 affected517 at risk
EG003
Injection Site Oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0009 events4 affected111 at risk
EG00184 events14 affected421 at risk
EG00232 events14 affected517 at risk
EG003
Injection Site Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG00018 events9 affected111 at risk
EG00128 events18 affected421 at risk
EG00240 events15 affected517 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA 22.0
Systematic Assessment
EG00023 events12 affected111 at risk
EG00154 events16 affected421 at risk
EG00236 events15 affected517 at risk
EG003
Injection Site Reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Injection Site Warmth
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Peripheral Swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG00112 events8 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Multiple Allergies
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00030 events15 affected111 at risk
EG001135 events80 affected421 at risk
EG002100 events63 affected517 at risk
EG003
Bronchitis Viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0015 events5 affected421 at risk
EG0025 events5 affected517 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0006 events6 affected111 at risk
EG0018 events7 affected421 at risk
EG00214 events10 affected517 at risk
EG003
Genital Herpes
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0013 events3 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0005 events5 affected111 at risk
EG00152 events44 affected421 at risk
EG00239 events30 affected517 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected111 at risk
EG0016 events6 affected421 at risk
EG0027 events6 affected517 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00047 events27 affected111 at risk
EG001208 events109 affected421 at risk
EG002149 events99 affected517 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0005 events1 affected111 at risk
EG00119 events9 affected421 at risk
EG0029 events6 affected517 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00021 events16 affected111 at risk
EG00157 events37 affected421 at risk
EG00230 events26 affected517 at risk
EG003
Pharyngitis Streptococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events1 affected421 at risk
EG0026 events6 affected517 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0012 events2 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG00117 events15 affected421 at risk
EG0026 events5 affected517 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0016 events3 affected421 at risk
EG0027 events6 affected517 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0008 events7 affected111 at risk
EG00111 events11 affected421 at risk
EG0027 events6 affected517 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00016 events9 affected111 at risk
EG00156 events33 affected421 at risk
EG00243 events32 affected517 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00030 events18 affected111 at risk
EG00187 events60 affected421 at risk
EG00296 events65 affected517 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0007 events5 affected111 at risk
EG00131 events26 affected421 at risk
EG00220 events17 affected517 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected111 at risk
EG00115 events11 affected421 at risk
EG00216 events13 affected517 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0009 events6 affected111 at risk
EG00144 events40 affected421 at risk
EG00231 events28 affected517 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG0015 events4 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG00127 events14 affected421 at risk
EG00213 events12 affected517 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG0018 events7 affected421 at risk
EG00212 events12 affected517 at risk
EG003
Intentional Overdose
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0013 events3 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0012 events1 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Lip Injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0015 events5 affected421 at risk
EG00210 events10 affected517 at risk
EG003
Stab Wound
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Tooth Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0022 events2 affected517 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
C-Reactive Protein Increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Epstein-Barr Virus Test Positive
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
White Blood Cells Urine Positive
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG00010 events9 affected111 at risk
EG00129 events23 affected421 at risk
EG00229 events23 affected517 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected111 at risk
EG00133 events30 affected421 at risk
EG00228 events23 affected517 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected111 at risk
EG0012 events2 affected421 at risk
EG0022 events2 affected517 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0016 events6 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected111 at risk
EG0016 events4 affected421 at risk
EG0029 events7 affected517 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 events5 affected111 at risk
EG00114 events14 affected421 at risk
EG0027 events7 affected517 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0022 events2 affected517 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG0016 events6 affected421 at risk
EG0028 events7 affected517 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected111 at risk
EG0014 events4 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pituitary Tumour Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected111 at risk
EG00113 events12 affected421 at risk
EG0028 events8 affected517 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00014 events13 affected111 at risk
EG001141 events47 affected421 at risk
EG00269 events47 affected517 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG0013 events3 affected421 at risk
EG00214 events7 affected517 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0013 events3 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0012 events2 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0016 events4 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0011 events1 affected421 at risk
EG0027 events7 affected517 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected111 at risk
EG0017 events6 affected421 at risk
EG0026 events6 affected517 at risk
EG003
Sleep Disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected111 at risk
EG00124 events16 affected421 at risk
EG00212 events10 affected517 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected111 at risk
EG00111 events10 affected421 at risk
EG0028 events8 affected517 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0015 events5 affected421 at risk
EG0023 events3 affected517 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 events3 affected111 at risk
EG00113 events13 affected421 at risk
EG00211 events11 affected517 at risk
EG003
Paranasal Sinus Discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0023 events2 affected517 at risk
EG003
Sputum Increased
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Upper Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0010 events0 affected421 at risk
EG0025 events3 affected517 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0015 events2 affected421 at risk
EG0025 events5 affected517 at risk
EG003
Dyshidrotic Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Papulopustular Rosacea
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Pityriasis Alba
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Rash Generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected421 at risk
EG0021 events1 affected517 at risk
EG003
Solar Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected111 at risk
EG0011 events1 affected421 at risk
EG0020 events0 affected517 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0005 events5 affected111 at risk
EG00119 events16 affected421 at risk
EG00220 events19 affected517 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
1013
OG00497
OG00590
OG00619
OG00714
789
OG00474
OG00570
OG00618
OG00713
Any treatment emergent SAE
Title
Measurements
OG00014
OG00142
OG00248
OG003106
OG00412
OG00510
OG0060
OG0074
Any TEAE leading to death
Title
Measurements
OG0000
OG0013
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
Any TEAE leading to permanent discontinuation
Title
Measurements
OG0003
OG00119
OG00212
OG00331
OG0044
OG0055
OG0061
OG0072
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
ParticipantsOG00497
ParticipantsOG00590
ParticipantsOG00619
ParticipantsOG00714
Title
Measurements
OG0004
OG00112
OG00219
OG003
SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
HR: ≤ 50 & DFB ≥ 20 bpm
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
HR: ≥ 120 & IFB ≥ 20 bpm
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Respiratory rate: < 12 b/m
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Respiratory rate: > 20 b/m
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Weight: ≥ 5% DFB
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Weight: ≥ 5% IFB
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002485
ParticipantsOG003958
Temperature: ≥ 38.0°C
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Temperature: ≥ 37.5°C
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Temperature: ≥ 37.2°C
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002516
ParticipantsOG0031013
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L)
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG0031009
ParticipantsOG00497
ParticipantsOG00590
ParticipantsOG00619
ParticipantsOG00714
Title
Measurements
OG0002
OG0017
OG00212
OG003
Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L)
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG0031009
Hb: DFB ≥ 20 g/L
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002513
ParticipantsOG0031008
Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v)
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG003
Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v)
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG003
RBCs: ≥ 6 Tera/L
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG0031009
Platelets: < 100G/ L
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG0031007
Platelets: ≥ 700 G/L
ParticipantsOG000111
ParticipantsOG001421
ParticipantsOG002514
ParticipantsOG0031007
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Title
Measurements
OG00062
OG001242
OG002234
OG003437
OG00435
OG00541
OG0063
OG0071
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Title
Measurements
OG0000.314
OG0010.330
OG0020.351
OG0030.331
OG0040.302
OG0050.391
OG0060.149
OG0070.077
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 48
ParticipantsOG000105
ParticipantsOG001396
ParticipantsOG002486
ParticipantsOG003951
ParticipantsOG00488
ParticipantsOG00582
ParticipantsOG00616
ParticipantsOG00711
Title
Measurements
OG0000.24± 0.42
OG0010.28± 0.45
OG0020.34± 0.44
OG003
Week 96
ParticipantsOG000102
ParticipantsOG001380
ParticipantsOG002219
ParticipantsOG003447
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 48
ParticipantsOG000105
ParticipantsOG001396
ParticipantsOG002486
ParticipantsOG003951
ParticipantsOG00488
ParticipantsOG00582
ParticipantsOG00616
ParticipantsOG00711
Title
Measurements
OG0009.21± 13.61
OG00110.42± 14.61
OG00211.74± 14.27
OG003
Week 96
ParticipantsOG000102
ParticipantsOG001380
ParticipantsOG002219
ParticipantsOG003447
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 48
ParticipantsOG000105
ParticipantsOG001396
ParticipantsOG002486
ParticipantsOG003951
ParticipantsOG00488
ParticipantsOG00582
ParticipantsOG00616
ParticipantsOG00711
Title
Measurements
OG0000.22± 0.45
OG0010.25± 0.50
OG0020.30± 0.48
OG003
Week 96
ParticipantsOG000102
ParticipantsOG001380
ParticipantsOG002219
ParticipantsOG003447
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 48
ParticipantsOG000105
ParticipantsOG001396
ParticipantsOG002486
ParticipantsOG003951
ParticipantsOG00488
ParticipantsOG00582
ParticipantsOG00616
ParticipantsOG00711
Title
Measurements
OG0000.27± 0.55
OG0010.31± 0.55
OG0020.39± 0.57
OG003
Week 96
ParticipantsOG000102
ParticipantsOG001380
ParticipantsOG002219
ParticipantsOG003447
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 24
ParticipantsOG000110
ParticipantsOG001421
ParticipantsOG002513
ParticipantsOG0031005
ParticipantsOG00496
ParticipantsOG00587
ParticipantsOG00619
ParticipantsOG00713
Title
Measurements
OG000-1.37± 0.91
OG001-1.48± 1.10
OG002-1.61± 1.08
OG003
Week 48
ParticipantsOG000105
ParticipantsOG001400
ParticipantsOG002488
ParticipantsOG003957
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 24
ParticipantsOG000110
ParticipantsOG001421
ParticipantsOG002513
ParticipantsOG0031005
ParticipantsOG00496
ParticipantsOG00587
ParticipantsOG00619
ParticipantsOG00713
Title
Measurements
OG00082.7
OG00180.8
OG00284.0
OG003
Week 48
ParticipantsOG000105
ParticipantsOG001400
ParticipantsOG002488
ParticipantsOG003957
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
Title
Denominators
Categories
Week 24
ParticipantsOG000108
ParticipantsOG001413
ParticipantsOG002495
ParticipantsOG003948
ParticipantsOG00495
ParticipantsOG00588
Title
Measurements
OG0001.07± 0.99
OG0011.28± 1.24
OG0021.38± 1.15
OG003
Week 48
ParticipantsOG000103
ParticipantsOG001397
ParticipantsOG002473
ParticipantsOG003908
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
Title
Denominators
Categories
Week 24
ParticipantsOG000108
ParticipantsOG001413
ParticipantsOG002495
ParticipantsOG003948
ParticipantsOG00495
ParticipantsOG00588
Title
Measurements
OG00067.6
OG00173.6
OG00277.6
OG003
Week 48
ParticipantsOG000103
ParticipantsOG001397
ParticipantsOG002473
ParticipantsOG003908
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002515
OG0031008
OG00496
OG00590
OG00619
OG00714
Title
Denominators
Categories
Baseline
ParticipantsOG000110
ParticipantsOG001413
ParticipantsOG0020
ParticipantsOG003993
ParticipantsOG0040
ParticipantsOG00588
ParticipantsOG0060
ParticipantsOG00714
Title
Measurements
OG0000.00± 0.000
OG0010.00± 1990.640
OG0030.00± 2286.888
OG005
Week 0
ParticipantsOG000110
ParticipantsOG001417
ParticipantsOG0020
ParticipantsOG003968
Week 4
ParticipantsOG000109
ParticipantsOG001414
ParticipantsOG002500
ParticipantsOG003971
Week 12
ParticipantsOG000111
ParticipantsOG001417
ParticipantsOG002501
ParticipantsOG003973
Week 24
ParticipantsOG000108
ParticipantsOG001405
ParticipantsOG002500
ParticipantsOG003973
Week 48
ParticipantsOG000106
ParticipantsOG001397
ParticipantsOG002484
ParticipantsOG003951
Week 72
ParticipantsOG000105
ParticipantsOG001385
ParticipantsOG002227
ParticipantsOG003453
Week 96
ParticipantsOG000101
ParticipantsOG001381
ParticipantsOG002222
ParticipantsOG003446
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG002
Participants From EFC13579: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002515
OG0031008
OG00495
OG00590
OG00619
OG00714
Title
Denominators
Categories
Treatment-emergent ADA
Title
Measurements
OG00010.8
OG00112.1
OG0029.5
OG0034.5
OG0047.4
OG0058.9
OG0060
OG0077.1
Treatment-boosted ADA
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG003
Participants From EFC13579: Dupilumab/Dupilumab
Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG004
Participants From EFC13691: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG005
Participants From EFC13691: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG006
Participants From PDY14192: Placebo/Dupilumab
Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
OG007
Participants From PDY14192: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
OG002517
OG0031013
OG00497
OG00590
OG00619
OG00714
Title
Denominators
Categories
Week 48
ParticipantsOG000103
ParticipantsOG001386
ParticipantsOG002474
ParticipantsOG003935
ParticipantsOG00487
ParticipantsOG00582
ParticipantsOG00614
ParticipantsOG00710
Title
Measurements
OG0000.007± 0.475
OG001-0.041± 0.588
OG002-0.096± 0.428
OG003
Week 96
ParticipantsOG000102
ParticipantsOG001381
ParticipantsOG002218
ParticipantsOG003435
Units
Counts
Participants
OG000111
OG001421
Title
Denominators
Categories
Week 48
ParticipantsOG000110
ParticipantsOG001407
Title
Measurements
OG00013.26± 76.71
OG00122.95± 70.06
Week 96
ParticipantsOG00092
ParticipantsOG001340
Title
Measurements
OG00013.63± 83.88
OG001
Units
Counts
Participants
OG000111
OG001421
Title
Denominators
Categories
Week 48
ParticipantsOG000109
ParticipantsOG001406
Title
Measurements
OG0004.65± 75.00
OG00111.97± 72.19
Week 96
ParticipantsOG00089
ParticipantsOG001327
Title
Measurements
OG0001.16± 79.47
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
Title
Denominators
Categories
Week 48
ParticipantsOG000110
ParticipantsOG001410
Title
Measurements
OG000-0.49± 0.78
OG001-0.68± 0.79
Week 96
ParticipantsOG00092
ParticipantsOG001324
Title
Measurements
OG000-0.52± 0.90
OG001
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Units
Counts
Participants
OG000111
OG001421
Title
Denominators
Categories
Week 48
ParticipantsOG000109
ParticipantsOG001407
Title
Measurements
OG000-0.47± 0.81
OG001-0.72± 0.85
Week 96
ParticipantsOG00088
ParticipantsOG001330
Title
Measurements
OG000-0.49± 0.94
OG001
Units
Counts
Participants
OG000111
OG001421
Title
Denominators
Categories
Week 48
ParticipantsOG000108
ParticipantsOG001406
Title
Measurements
OG000-0.00± 3.65
OG0010.68± 4.80
Week 96
ParticipantsOG00088
ParticipantsOG001325
Title
Measurements
OG000-0.14± 4.17
OG001
Units
Counts
Participants
OG000111
OG001421
Title
Denominators
Categories
Week 48
ParticipantsOG000110
ParticipantsOG001410
Title
Measurements
OG000-0.27± 0.54
OG001-0.43± 0.89
Week 96
ParticipantsOG00092
ParticipantsOG001344
Title
Measurements
OG000-0.29± 0.58
OG001
Units
Counts
Participants
OG00097
OG00190
Title
Denominators
Categories
Week 48
ParticipantsOG00077
ParticipantsOG00157
Title
Measurements
OG00055.32± 42.98
OG00180.23± 30.44
Week 96
ParticipantsOG00028
ParticipantsOG00119
Title
Measurements
OG00071.37± 29.37
OG001
Units
Counts
Participants
OG00097
OG00190
Title
Denominators
Categories
Week 48
ParticipantsOG00077
ParticipantsOG00157
Title
Measurements
OG00064.9
OG00186.0
Week 96
ParticipantsOG00028
ParticipantsOG00119
Title
Measurements
OG00082.1
OG001
Units
Counts
Participants
OG00097
OG00190
Title
Denominators
Categories
Week 48
ParticipantsOG00077
ParticipantsOG00157
Title
Measurements
OG00031.2
OG00159.6
Week 96
ParticipantsOG00028
ParticipantsOG00119
Title
Measurements
OG00042.9
OG001
OG001
Participants From DRI12544: Dupilumab/Dupilumab
Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.