A Study of the Effect of IW-1701 (Olinciguat), a Stimulat... | NCT03285178 | Trialant
NCT03285178
Sponsor
Cyclerion Therapeutics
Status
Completed
Last Update Posted
Jul 21, 2023Actual
Enrollment
88Actual
Phase
Phase 2
Conditions
Sickle Cell Disease
Interventions
IW-1701
Placebo
Countries
United States
Lebanon
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03285178
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C1701-202
Secondary IDs
Not provided
Brief Title
A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)
Official Title
A Randomized, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Pharmacodynamics of Once-daily Oral IW-1701 in Patients With Stable Sickle Cell Disease
Acronym
STRONG SCD
Organization
Cyclerion TherapeuticsINDUSTRY
Status Module
Record Verification Date
Jul 2023
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
Dec 22, 2017Actual
Primary Completion Date
Jul 22, 2020Actual
Completion Date
Jul 22, 2020Actual
First Submitted Date
Sep 8, 2017
First Submission Date that Met QC Criteria
Sep 13, 2017
First Posted Date
Sep 15, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 21, 2023
Results First Submitted that Met QC Criteria
Jul 19, 2023
Results First Posted Date
Jul 21, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 18, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 21, 2023Actual
Last Update Submitted Date
Jul 19, 2023
Last Update Posted Date
Jul 21, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Cyclerion TherapeuticsINDUSTRY
Collaborators
Not provided
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
The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of different dose levels of IW-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation of pharmacokinetic (PK) as well as evaluation of the effect of IW-1701 on symptoms of SCD, health-related quality of life, and biomarkers of pharmacodynamic (PD) activity.
Detailed Description
Not provided
Conditions Module
Conditions
Sickle Cell Disease
Keywords
Sickle Cell Disease
SCD
Olinciguat
IW-1701
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
88Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
IW-1701 (Olinciguat) 2 mg
Experimental
After a single-blind treatment with placebo once daily (QD) for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 1 mg olinciguat QD Week 1 and 2 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Drug: IW-1701
IW-1701 (Olinciguat) 4 mg
Experimental
After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 2 mg olinciguat QD Week 1 and 4 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Drug: IW-1701
IW-1701 (Olinciguat) 6 mg
Experimental
After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 3 mg olinciguat QD Week 1 and 6 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Drug: IW-1701
IW-1701 (Olinciguat) 18 mg
Experimental
After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 6 mg olinciguat QD Days 1-7, 12 mg olinciguat QD Weeks 1-3, and 18 mg olinciguat QD Weeks 4-12 under protocol Amendment 4 and later.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IW-1701
Drug
Oral Tablet
IW-1701 (Olinciguat) 18 mg
IW-1701 (Olinciguat) 2 mg
IW-1701 (Olinciguat) 4 mg
IW-1701 (Olinciguat) 6 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. Adverse Events of special interest (AESIs) included symptomatic or Grade ≥2 hypotensive events and/or tachycardia AEs, bleeding events, pulmonary edema, and bone-related events, including fractures.
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Double-Blind Treatment: Number of TEAE Events
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA
Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.
Patient has SCD, including homozygous hemoglobin S (HbSS), hemoglobin SC disease (HbSC), heterozygous hemoglobin S-beta zero (HbSβ0)-thalassemia, or heterozygous hemoglobin S-beta plus (HbSβ+)-thalassemia, documented in their medical history.
If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable regimen.
Per medical history and/or patient recall, patient has had at least 1 and no more than 10 sickle cell-related pain crises in the 12 months before the Screening Visit and none occurring in the 4 weeks before the Randomization Visit.
Patient completes daily eDiary entries for at least 10 days during the last 14 days of the Run in Period as assessed at the Randomization Visit.
Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 90 days after the final dose of study drug.
Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception and agree to refrain from sperm donation from the Screening Visit through 90 days after the final dose of study drug.
EXCLUSION CRITERIA
Patient requires a program of prescheduled, regularly administered chronic blood transfusion therapy.
Patient has been hospitalized for an SCD-related complication in the 4 weeks before the Randomization Visit.
Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before the Randomization Visit.
Patient is taking aspirin ≥325 mg daily, P2Y12 inhibitors, any anticoagulant medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of phosphodiesterase 5 (PDE5), moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors in any form.
Patient has major concurrent illness or medical condition that in the opinion of the Investigator would preclude participation in a clinical study.
NOTE: Other inclusion and exclusion criteria apply, per protocol
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
16 Years
Maximum Age
70 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Children's Hospital of Orange County
Orange
California
92868
United States
MedStar Health Research Institute, MedStar Washington Hospital Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
After a 2-week single-blind placebo Run-in, eligible participants were stratified by hydroxyurea (hydroxycarbamide [HU]) use (yes or no) and randomly assigned to double-blind study drug (olinciguat or placebo).
Under Amendment 3 and earlier: Participants were assigned in a 1:1:1:1 ratio to placebo, 2 mg olinciguat, 4 mg olinciguat, or 6 mg olinciguat.
Under Amendment 4 and later: Participants were assigned in a 3:1 ratio to 18 mg olinciguat or placebo.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Single-Blind Run-in: Placebo
Single-blind treatment with placebo once daily (QD) for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1.
After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received placebo treatment QD for 12 weeks.
Drug: Placebo
Olinciguat
Placebo
Drug
Oral Tablet
Placebo
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the most severe occurrence was counted.
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Washington D.C.
District of Columbia
20010
United States
Howard University Center for Sickle Cell Disease
Washington D.C.
District of Columbia
20060
United States
Innovative Medical Research of South Florida, Inc.
Aventura
Florida
33180
United States
Century Clinical Research, Inc.
Fort Lauderdale
Florida
32117
United States
Foundation for Sickle Cell Disease Research
Hollywood
Florida
33021
United States
Omega Research Maitland, LLC
Orlando
Florida
32810
United States
Grady Memorial Hospital
Atlanta
Georgia
30303
United States
Atlanta Center for Medical Research
Atlanta
Georgia
30331
United States
University of Illinois at Chicago
Chicago
Illinois
60612
United States
Healthcare Research Network II, LLC
Flossmoor
Illinois
60422
United States
Clinical Trials of SWLA, LLC
Lake Charles
Louisiana
70601
United States
University of Maryland Medical Center
Baltimore
Maryland
21201
United States
Johns Hopkins School of Medicine Children's Center
Baltimore
Maryland
21205
United States
Boston Children's Hospital
Boston
Massachusetts
02115
United States
Children's Hospital of Michigan-Detroit
Detroit
Michigan
33021
United States
Healthcare Research Network
Hazelwood
Missouri
63042
United States
Hackensack University Medical Center, Pediatric Hematology and Oncology
Hackensack
New Jersey
07601
United States
Jacobi Medical Center
The Bronx
New York
10461
United States
New York Medical College
Valhalla
New York
10595
United States
East Carolina University - Leo W. Jenkins Cancer Center
Greenville
North Carolina
27834
United States
East Carolina University Brody School of Medicine, Department of Pediatrics, Division of Pediatric Hematology
Greenville
North Carolina
27834
United States
Lynn Institute of Tulsa
Tulsa
Oklahoma
74105
United States
The Clinical Trial Center LLC
Jenkintown
Pennsylvania
19046
United States
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh
Pennsylvania
15232
United States
Accurate Clinical Research
Baytown
Texas
77521
United States
"UT Health Clinical Research Unit Center for Clinical and Translational Sciences
Houston
Texas
77030
United States
Mays Cancer Center UT Health San Antonio
San Antonio
Texas
78229
United States
Virginia Commonwealth University - Clinical Research Unit
Richmond
Virginia
23298
United States
Blood Center of Wisconsin (BCW)
Wauwatosa
Wisconsin
53226
United States
Hammoud Hospital University Medical Center
Sidon
Lebanon
Nini Hospital
Tripoli
Lebanon
Royal London Hospital
London
E1 2ES
United Kingdom
Whittington Hospital
London
N19 5NF
United Kingdom
Guys and St Thomas NHS Foundation Trust - Evelina London Childrens Hospital
London
SE1 7EH
United Kingdom
Guy's Hospital
London
SE1 9RT
United Kingdom
Hammersmith Hospital
London
W12 0NN
United Kingdom
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
FG002
Double-Blind Treatment: Placebo 2
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
FG003
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
Participants received 1 mg olinciguat QD Week 1 and 2 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
FG004
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
Participants received 2 mg olinciguat QD Week 1 and 4 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
FG005
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
Participants received 3 mg olinciguat QD Week 1 and 6 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Participants received 6 mg olinciguat QD Days 1-7, 12 mg olinciguat QD Weeks 1-3, and 18 mg olinciguat QD Weeks 4-12 under protocol Amendment 4 and later.
FG00088 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00070 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00018 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
COVID-19 Pandemic Precautions - Suspended by Institutional Review Board (IRB)
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COVID-19 Pandemic Precautions- Suspended per Local Guidelines
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG00011 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Double-Blind Treatment Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00110 subjects
FG0029 subjects
FG0038 subjects
FG0048 subjects
FG00511 subjects
FG00624 subjects
COMPLETED
FG0000 subjects
FG0018 subjects
FG0026 subjects
FG0037 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Randomized Mistakenly During the Run-In Period - Did Not Receive Study Drug
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG003
Safety Population: Randomized participants who received at least 1 dose of study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Double-Blind Treatment: Placebo 1
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
BG001
Double-Blind Treatment: Placebo 2
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later
BG002
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
Participants received 1 mg olinciguat QD Week 1 and 2 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
BG003
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
Participants received 2 mg olinciguat QD Week 1 and 4 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
BG004
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
Participants received 3 mg olinciguat QD Week 1 and 6 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Participants received 6 mg olinciguat QD Days 1-7, 12 mg olinciguat QD Weeks 1-3, and 18 mg olinciguat QD Weeks 4-12 under protocol Amendment 4 and later.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG0018
BG0028
BG0038
BG00411
BG00524
BG00668
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00030.3± 9.43
BG00131.5± 9.29
BG00226.3± 10.51
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Black or African American
BG0008
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
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
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. Adverse Events of special interest (AESIs) included symptomatic or Grade ≥2 hypotensive events and/or tachycardia AEs, bleeding events, pulmonary edema, and bone-related events, including fractures.
Safety Population: Randomized participants who received at least 1 dose of study drug
Posted
Count of Participants
Participants
No
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
ID
Title
Description
OG000
Double-Blind Treatment: Placebo 1
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
OG001
Double-Blind Treatment: Placebo 2
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
OG002
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
Participants received 1 mg olinciguat QD Week 1 and 2 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
OG003
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
Participants received 2 mg olinciguat QD Week 1 and 4 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
OG004
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
Participants received 3 mg olinciguat QD Week 1 and 6 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Participants received 6 mg olinciguat QD Days 1-7, 12 mg olinciguat QD Weeks 1-3, and 18 mg olinciguat QD Weeks 4-12 under protocol Amendment 4 and later.
Units
Counts
Participants
OG0009
OG0018
OG0028
OG003
Title
Denominators
Categories
Participants with >=1 TEAE
Title
Measurements
OG0006
OG0016
OG0025
OG003
Primary
Double-Blind Treatment: Number of TEAE Events
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.
Safety Population: Randomized participants who received at least 1 dose of study drug. Participants with >=1 TEAE.
Posted
Number
TEAE Events
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
ID
Title
Description
OG000
Placebo 1
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
OG001
Placebo 2
Participants receiving treatment under protocol Amendment 4 and later
Primary
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the most severe occurrence was counted.
Safety Population: Randomized participants who received at least 1 dose of study drug
Posted
Count of Participants
Participants
No
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
ID
Title
Description
OG000
Placebo 1
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
OG001
Placebo 2
Participants receiving treatment under protocol Amendment 4 and later
Primary
Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.
Safety Population: Randomized participants who received at least 1 dose of study drug
Posted
Count of Participants
Participants
No
First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
ID
Title
Description
OG000
Placebo 1
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
OG001
Placebo 2
Participants receiving treatment under protocol Amendment 4 and later
Time Frame
AEs during Single-blind Run-in Period were collected from first dose of Run-in placebo up to the first dose of randomized study drug, up to 17 days. AEs during the Double-Blind Period: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
Description
All Cause mortality was collected for the duration of the study, mean 141.2 days.
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
Single-Blind Run-in Period: Placebo
Single-blind treatment with placebo for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1.
0
88
2
88
18
88
EG001
Double-Blind Treatment Period: Placebo 1
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
0
9
2
9
6
9
EG002
Double-Blind Treatment Period: Placebo 2
Participants receiving treatment under protocol Amendment 4 and later
Participants receiving treatment under protocol Amendment 4 and later
0
24
6
24
20
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
SICKLE CELL ANAEMIA WITH CRISIS
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG0032 affected8 at risk
EG004
ACUTE CHEST SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
APLASTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
IMPAIRED GASTRIC EMPTYING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected88 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG0032 affected8 at risk
EG0040 affected8 at risk
EG0050 affected11 at risk
EG0061 affected24 at risk
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
GINGIVITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
SICKLE CELL ANAEMIA WITH CRISIS
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected88 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0012 affected9 at risk
EG0022 affected8 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0012 affected9 at risk
EG0020 affected8 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected88 at risk
EG0011 affected9 at risk
EG0022 affected8 at risk
EG003
FATIGUE
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0012 affected9 at risk
EG0020 affected8 at risk
EG003
SUPRAPUBIC PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PARANASAL SINUS DISCOMFORT
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
THROAT IRRITATION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPOAESTHESIA ORAL
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
IMPAIRED GASTRIC EMPTYING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
JOINT STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
OSTEONECROSIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
TRIGEMINAL NEURALGIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
PYREXIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
CHILLS
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
EARLY SATIETY
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
VESSEL PUNCTURE SITE PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
INFUSION SITE EXTRAVASATION
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
AMYLASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ACUTE PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
MUMPS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0012 affected9 at risk
EG0020 affected8 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
RENAL PAIN
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
SKIN REACTION
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
PERIORBITAL SWELLING
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
GENITAL DISCOLOURATION
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
OVARIAN CYST
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
PYLORIC STENOSIS
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
DEVICE MALFUNCTION
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected88 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.