Trial Outcomes & Findings for A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD) (NCT NCT03285178)

NCT ID: NCT03285178

Last Updated: 2023-07-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

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.

Results posted on

2023-07-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
Double-Blind Treatment: Placebo 1
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
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.
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.
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
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.
Single-Blind Run-In Period
STARTED
88
0
0
0
0
0
0
Single-Blind Run-In Period
COMPLETED
70
0
0
0
0
0
0
Single-Blind Run-In Period
NOT COMPLETED
18
0
0
0
0
0
0
Double-Blind Treatment Period
STARTED
0
10
9
8
8
11
24
Double-Blind Treatment Period
COMPLETED
0
8
6
7
6
9
21
Double-Blind Treatment Period
NOT COMPLETED
0
2
3
1
2
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Double-Blind Treatment: Placebo 1
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
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.
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.
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
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.
Single-Blind Run-In Period
COVID-19 Pandemic Precautions - Suspended by Institutional Review Board (IRB)
3
0
0
0
0
0
0
Single-Blind Run-In Period
COVID-19 Pandemic Precautions- Suspended per Local Guidelines
1
0
0
0
0
0
0
Single-Blind Run-In Period
Protocol Violation
11
0
0
0
0
0
0
Single-Blind Run-In Period
Withdrawal by Subject
1
0
0
0
0
0
0
Single-Blind Run-In Period
Physician Decision
2
0
0
0
0
0
0
Double-Blind Treatment Period
Randomized Mistakenly During the Run-In Period - Did Not Receive Study Drug
0
1
1
0
0
0
0
Double-Blind Treatment Period
Adverse Event
0
0
0
0
0
0
2
Double-Blind Treatment Period
Lost to Follow-up
0
1
0
0
2
0
0
Double-Blind Treatment Period
Withdrawal by Subject
0
0
1
1
0
2
1
Double-Blind Treatment Period
COVID-19
0
0
1
0
0
0
0

Baseline Characteristics

A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Double-Blind Treatment: Placebo 1
n=9 Participants
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
n=8 Participants
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
n=11 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
n=24 Participants
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.
Total
n=68 Participants
Total of all reporting groups
Age, Continuous
30.3 years
STANDARD_DEVIATION 9.43 • n=99 Participants
31.5 years
STANDARD_DEVIATION 9.29 • n=107 Participants
26.3 years
STANDARD_DEVIATION 10.51 • n=206 Participants
34.5 years
STANDARD_DEVIATION 11.38 • n=7 Participants
34.4 years
STANDARD_DEVIATION 13.34 • n=31 Participants
32.7 years
STANDARD_DEVIATION 12.63 • n=30 Participants
32.0 years
STANDARD_DEVIATION 11.5 • n=3 Participants
Sex: Female, Male
Female
7 Participants
n=99 Participants
5 Participants
n=107 Participants
5 Participants
n=206 Participants
7 Participants
n=7 Participants
6 Participants
n=31 Participants
14 Participants
n=30 Participants
44 Participants
n=3 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
3 Participants
n=107 Participants
3 Participants
n=206 Participants
1 Participants
n=7 Participants
5 Participants
n=31 Participants
10 Participants
n=30 Participants
24 Participants
n=3 Participants
Race/Ethnicity, Customized
Black or African American
8 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
8 Participants
n=7 Participants
10 Participants
n=31 Participants
15 Participants
n=30 Participants
53 Participants
n=3 Participants
Race/Ethnicity, Customized
White
0 Participants
n=99 Participants
4 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
9 Participants
n=30 Participants
13 Participants
n=3 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
1 Participants
n=30 Participants
3 Participants
n=3 Participants
Race/Ethnicity, Customized
Hispanic or Latino
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
2 Participants
n=3 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
7 Participants
n=99 Participants
7 Participants
n=107 Participants
6 Participants
n=206 Participants
8 Participants
n=7 Participants
10 Participants
n=31 Participants
22 Participants
n=30 Participants
60 Participants
n=3 Participants
Race/Ethnicity, Customized
Unknown
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
1 Participants
n=30 Participants
3 Participants
n=3 Participants

PRIMARY outcome

Timeframe: 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.

Population: Safety Population: Randomized participants who received at least 1 dose of study drug

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.

Outcome measures

Outcome measures
Measure
Double-Blind Treatment: Placebo 1
n=9 Participants
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
n=8 Participants
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
n=11 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
n=24 Participants
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.
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with >=1 TEAE
6 Participants
6 Participants
5 Participants
5 Participants
8 Participants
21 Participants
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with >=1 SAE
2 Participants
1 Participants
2 Participants
3 Participants
4 Participants
6 Participants
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with >=1 TEAE Leading to Study Drug Discontinuation
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with >=1 AESI
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with >=1 Grade 3-5 TEAE
2 Participants
2 Participants
2 Participants
3 Participants
4 Participants
7 Participants
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with >=1 Study Drug-Related TEAE
3 Participants
0 Participants
2 Participants
0 Participants
4 Participants
7 Participants

PRIMARY outcome

Timeframe: 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.

Population: Safety Population: Randomized participants who received at least 1 dose of study drug. Participants with \>=1 TEAE.

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.

Outcome measures

Outcome measures
Measure
Double-Blind Treatment: Placebo 1
n=6 Participants
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
n=6 Participants
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
n=5 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
n=5 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
n=21 Participants
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.
Double-Blind Treatment: Number of TEAE Events
26 TEAE Events
29 TEAE Events
36 TEAE Events
30 TEAE Events
39 TEAE Events
101 TEAE Events

PRIMARY outcome

Timeframe: 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.

Population: Safety Population: Randomized participants who received at least 1 dose of study drug

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.

Outcome measures

Outcome measures
Measure
Double-Blind Treatment: Placebo 1
n=9 Participants
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
n=8 Participants
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
n=11 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
n=24 Participants
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.
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Participants with ≥1 TEAE: Any
6 Participants
6 Participants
5 Participants
5 Participants
8 Participants
21 Participants
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Participants with ≥1 TEAE: Grade 1
0 Participants
4 Participants
0 Participants
2 Participants
2 Participants
6 Participants
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Participants with ≥1 TEAE: Grade 3
2 Participants
2 Participants
2 Participants
3 Participants
4 Participants
7 Participants
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Participants with ≥1 TEAE: Grade 4
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Participants with ≥1 TEAE: Grade 2
4 Participants
0 Participants
3 Participants
0 Participants
2 Participants
8 Participants
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum Severity
Participants with ≥1 TEAE: Grade 5
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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.

Population: Safety Population: Randomized participants who received at least 1 dose of study drug

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.

Outcome measures

Outcome measures
Measure
Double-Blind Treatment: Placebo 1
n=9 Participants
Participants received placebo treatment QD for 12 weeks under the original protocol, Amendment 1, Amendment 2, and Amendment 3.
Double-Blind Treatment: Placebo 2
n=8 Participants
Participants received placebo treatment QD for 12 weeks under protocol Amendment 4 and later.
Double-Blind Treatment: IW-1701 (Olinciguat) 2 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 4 mg
n=8 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 6 mg
n=11 Participants
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.
Double-Blind Treatment: IW-1701 (Olinciguat) 18 mg
n=24 Participants
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.
Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEs
3 Participants
0 Participants
2 Participants
0 Participants
4 Participants
7 Participants

Adverse Events

Single-Blind Run-in Period: Placebo

Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths

Double-Blind Treatment Period: Placebo 1

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

Double-Blind Treatment Period: Placebo 2

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg

Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths

Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg

Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths

Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg

Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths

Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg

Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Single-Blind Run-in Period: Placebo
n=88 participants at risk
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.
Double-Blind Treatment Period: Placebo 1
n=9 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
Double-Blind Treatment Period: Placebo 2
n=8 participants at risk
Participants receiving treatment under protocol Amendment 4 and later
Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg
n=8 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg
n=8 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3I
Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg
n=11 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg
n=24 participants at risk
Participants receiving treatment under protocol Amendment 4 and later
Blood and lymphatic system disorders
SICKLE CELL ANAEMIA WITH CRISIS
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
37.5%
3/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
27.3%
3/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
3/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
ACUTE CHEST SYNDROME
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Blood and lymphatic system disorders
APLASTIC ANAEMIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Reproductive system and breast disorders
MENORRHAGIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
NON-CARDIAC CHEST PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
PNEUMONIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
ABDOMINAL PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.

Other adverse events

Other adverse events
Measure
Single-Blind Run-in Period: Placebo
n=88 participants at risk
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.
Double-Blind Treatment Period: Placebo 1
n=9 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
Double-Blind Treatment Period: Placebo 2
n=8 participants at risk
Participants receiving treatment under protocol Amendment 4 and later
Double-Blind Treatment Period: IW-1701 (Olinciguat) 2 mg
n=8 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
Double-Blind Treatment Period: IW-1701 (Olinciguat) 4 mg
n=8 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3I
Double-Blind Treatment Period: IW-1701 (Olinciguat) 6 mg
n=11 participants at risk
Participants receiving treatment under the original protocol, Amendment 1, Amendment 2, and Amendment 3
Double-Blind Treatment Period: IW-1701 (Olinciguat) 18 mg
n=24 participants at risk
Participants receiving treatment under protocol Amendment 4 and later
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
20.8%
5/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
URINARY TRACT INFECTION
2.3%
2/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
BRONCHITIS
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
GINGIVITIS
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Blood and lymphatic system disorders
SICKLE CELL ANAEMIA WITH CRISIS
3.4%
3/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
37.5%
3/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
3/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
DIARRHOEA
2.3%
2/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
SKIN REACTION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
BACK PAIN
4.5%
4/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
ABDOMINAL PAIN
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
NAUSEA
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
22.2%
2/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
18.2%
2/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
VOMITING
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
22.2%
2/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
3/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
HEADACHE
3.4%
3/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
18.2%
2/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
6/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
FATIGUE
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
22.2%
2/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
SUPRAPUBIC PAIN
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS DISCOMFORT
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Metabolism and nutrition disorders
DECREASED APPETITE
1.1%
1/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
3/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
DYSPEPSIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
TOOTHACHE
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
CONSTIPATION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
ABDOMINAL DISTENSION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
HYPOAESTHESIA ORAL
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
DYSGEUSIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
TRIGEMINAL NEURALGIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
DIZZINESS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
HYPOAESTHESIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
PARAESTHESIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Nervous system disorders
SOMNOLENCE
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Blood and lymphatic system disorders
ANAEMIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Blood and lymphatic system disorders
LEUKOCYTOSIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
NON-CARDIAC CHEST PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
PYREXIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
CHILLS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
EARLY SATIETY
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
VESSEL PUNCTURE SITE PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
INFLUENZA LIKE ILLNESS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
INFUSION SITE EXTRAVASATION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
General disorders
PERIPHERAL SWELLING
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
AMYLASE INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
BLOOD PRESSURE INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
BLOOD BILIRUBIN INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
WEIGHT INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
8.3%
2/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
HYPOXIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
COUGH
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Respiratory, thoracic and mediastinal disorders
WHEEZING
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
GASTROENTERITIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
PNEUMONIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
SEPSIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
EAR INFECTION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
MUMPS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
NASOPHARYNGITIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
22.2%
2/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Metabolism and nutrition disorders
HYPERKALAEMIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Renal and urinary disorders
PROTEINURIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Renal and urinary disorders
RENAL PAIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
PRURITUS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
RASH
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
INGROWING NAIL
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
DRY SKIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
PAIN OF SKIN
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Skin and subcutaneous tissue disorders
SKIN ULCER
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Cardiac disorders
TACHYCARDIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Cardiac disorders
SINUS TACHYCARDIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Eye disorders
PERIORBITAL SWELLING
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Eye disorders
VISION BLURRED
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Reproductive system and breast disorders
GENITAL DISCOLOURATION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
4.2%
1/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Reproductive system and breast disorders
MENORRHAGIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Reproductive system and breast disorders
DYSMENORRHOEA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Reproductive system and breast disorders
OVARIAN CYST
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Congenital, familial and genetic disorders
PYLORIC STENOSIS
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Immune system disorders
DRUG HYPERSENSITIVITY
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
11.1%
1/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Product Issues
DEVICE MALFUNCTION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Psychiatric disorders
INSOMNIA
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
9.1%
1/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Psychiatric disorders
ANXIETY
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
12.5%
1/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
Vascular disorders
HYPOTENSION
0.00%
0/88 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/9 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
25.0%
2/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/8 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/11 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.
0.00%
0/24 • 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.
All Cause mortality was collected for the duration of the study, mean 141.2 days.

Additional Information

Senior Medical Director

Cyclerion Therapeutics, Inc.

Phone: 1-857-327-8778

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER