Trial Outcomes & Findings for Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain (NCT NCT03585270)
NCT ID: NCT03585270
Last Updated: 2024-01-10
Results Overview
Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms and Computed Tomography scans.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
409 participants
Primary outcome timeframe
Up to 14 days post-study drug initiation
Results posted on
2024-01-10
Participant Flow
The study was conducted from 03 February 2019 to 18 November 2022.
Of 453 participants screened, 409 were enrolled in the study and randomized to study treatment.
Participant milestones
| Measure |
Clazosentan
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
206
|
|
Overall Study
Not Treated
|
1
|
2
|
|
Overall Study
Started Treatment (Assigned Treatment Groups)
|
202
|
204
|
|
Overall Study
Started Treatment (Actual Treatment Received)
|
207
|
199
|
|
Overall Study
COMPLETED
|
187
|
189
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
| Measure |
Clazosentan
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Withdrawal by proxy/legal representative
|
1
|
0
|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Other reasons
|
2
|
2
|
Baseline Characteristics
Data not available for 6 participants
Baseline characteristics by cohort
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 10.4 • n=202 Participants
|
53.7 years
STANDARD_DEVIATION 10.0 • n=204 Participants
|
53.3 years
STANDARD_DEVIATION 10.2 • n=406 Participants
|
|
Age, Customized
Between 18 and 64 years
|
171 Participants
n=202 Participants
|
175 Participants
n=204 Participants
|
346 Participants
n=406 Participants
|
|
Age, Customized
Between 65 to 84 years
|
31 Participants
n=202 Participants
|
29 Participants
n=204 Participants
|
60 Participants
n=406 Participants
|
|
Age, Customized
85 years and older
|
0 Participants
n=202 Participants
|
0 Participants
n=204 Participants
|
0 Participants
n=406 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=202 Participants
|
137 Participants
n=204 Participants
|
275 Participants
n=406 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=202 Participants
|
67 Participants
n=204 Participants
|
131 Participants
n=406 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=202 Participants
|
23 Participants
n=204 Participants
|
48 Participants
n=406 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=202 Participants
|
159 Participants
n=204 Participants
|
314 Participants
n=406 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=202 Participants
|
22 Participants
n=204 Participants
|
44 Participants
n=406 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
3 Participants
n=204 Participants
|
3 Participants
n=406 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=202 Participants
|
6 Participants
n=204 Participants
|
10 Participants
n=406 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=204 Participants
|
0 Participants
n=406 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=202 Participants
|
5 Participants
n=204 Participants
|
11 Participants
n=406 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=202 Participants
|
169 Participants
n=204 Participants
|
345 Participants
n=406 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=204 Participants
|
0 Participants
n=406 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=202 Participants
|
21 Participants
n=204 Participants
|
37 Participants
n=406 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=202 Participants
|
6 participants
n=204 Participants
|
12 participants
n=406 Participants
|
|
Region of Enrollment
Belgium
|
15 participants
n=202 Participants
|
17 participants
n=204 Participants
|
32 participants
n=406 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=202 Participants
|
12 participants
n=204 Participants
|
20 participants
n=406 Participants
|
|
Region of Enrollment
Czechia
|
23 participants
n=202 Participants
|
24 participants
n=204 Participants
|
47 participants
n=406 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=202 Participants
|
3 participants
n=204 Participants
|
5 participants
n=406 Participants
|
|
Region of Enrollment
Finland
|
14 participants
n=202 Participants
|
11 participants
n=204 Participants
|
25 participants
n=406 Participants
|
|
Region of Enrollment
France
|
15 participants
n=202 Participants
|
18 participants
n=204 Participants
|
33 participants
n=406 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=202 Participants
|
16 participants
n=204 Participants
|
42 participants
n=406 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=202 Participants
|
3 participants
n=204 Participants
|
7 participants
n=406 Participants
|
|
Region of Enrollment
Israel
|
6 participants
n=202 Participants
|
7 participants
n=204 Participants
|
13 participants
n=406 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=202 Participants
|
18 participants
n=204 Participants
|
29 participants
n=406 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=202 Participants
|
11 participants
n=204 Participants
|
16 participants
n=406 Participants
|
|
Region of Enrollment
Spain
|
24 participants
n=202 Participants
|
24 participants
n=204 Participants
|
48 participants
n=406 Participants
|
|
Region of Enrollment
Sweden
|
8 participants
n=202 Participants
|
10 participants
n=204 Participants
|
18 participants
n=406 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=202 Participants
|
24 participants
n=204 Participants
|
59 participants
n=406 Participants
|
|
Body Mass Index
|
26.8 kilograms per square meter
STANDARD_DEVIATION 5.7 • n=200 Participants • Data not available for 6 participants
|
26.8 kilograms per square meter
STANDARD_DEVIATION 5.6 • n=200 Participants • Data not available for 6 participants
|
26.8 kilograms per square meter
STANDARD_DEVIATION 5.6 • n=400 Participants • Data not available for 6 participants
|
|
Total Glasgow Coma Scale (GCS) Score
|
13.4 units on a scale
STANDARD_DEVIATION 3.0 • n=201 Participants • Data not available for 2 participants.
|
13.1 units on a scale
STANDARD_DEVIATION 3.3 • n=203 Participants • Data not available for 2 participants.
|
13.2 units on a scale
STANDARD_DEVIATION 3.2 • n=404 Participants • Data not available for 2 participants.
|
|
World Federation of Neurological Societies (WFNS) Grade
Grade I and II
|
161 Participants
n=202 Participants
|
158 Participants
n=204 Participants
|
319 Participants
n=406 Participants
|
|
World Federation of Neurological Societies (WFNS) Grade
Grade III to V
|
41 Participants
n=202 Participants
|
46 Participants
n=204 Participants
|
87 Participants
n=406 Participants
|
|
Aneurysmal subarachnoid hemorrhage diagnosed subgroups
Confirmed vasospasm group
|
6 Participants
n=202 Participants
|
5 Participants
n=204 Participants
|
11 Participants
n=406 Participants
|
|
Aneurysmal subarachnoid hemorrhage diagnosed subgroups
High risk of vasospasm (high-risk prevention) group
|
196 Participants
n=202 Participants
|
199 Participants
n=204 Participants
|
395 Participants
n=406 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days post-study drug initiationPopulation: Full Analysis Set
Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms and Computed Tomography scans.
Outcome measures
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: At Day 16 post study drug initiationPopulation: Full Analysis Set
A clinical relevant cerebral infarction was defined as: all-cause cerebral infraction greater than or equal to 5 cm\^3 or cerebral infarction less than 5 cm\^3 in participants with clinical deterioration due to delayed cerebral ischemia. Cerebral infarction refers to new or worsened infarcts and was determined by a central radiology review comparing the total volume of infarcts on the computed tomography (CT) scan performed 16 days after study drug initiation with the total volume on the CT scan performed just prior to randomization.
Outcome measures
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Occurrence of Clinically Relevant Cerebral Infarction at Day 16 Post-study Drug Initiation
|
15 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At Week 12 post-aneurysmal subarachnoid hemorrhage (aSAH)Population: Full Analysis Set.
The modified Rankin Scale (mRS) was used to measure the degree of disability in participants who had a ruptured saccular aneurysm and were at a high risk of developing a delayed cerebral infarction (DCI). The mRS is scored by the physician. The mRS scores ranged from 0 (no symptoms) to 6 (dead). The mRS score was dichotomized into poor outcome (score greater and equal to 3) and good outcome (score less than 3).
Outcome measures
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Long-term Clinical Outcome Assessed by the Modified Rankin Scale (mRS) at Week 12 Post-aneurysmal Subarachnoid Hemorrhage (aSAH)
Participants with a mRS score of equal and greater than 3
|
50 Participants
|
41 Participants
|
|
Long-term Clinical Outcome Assessed by the Modified Rankin Scale (mRS) at Week 12 Post-aneurysmal Subarachnoid Hemorrhage (aSAH)
Participants with a mRS score of less than 3
|
152 Participants
|
163 Participants
|
SECONDARY outcome
Timeframe: At Week 12 post-aneurysmal subarachnoid hemorrhage (aSAH)Population: Full Analysis Set
The Glasgow Outcome Scale - Extended (GOSE) is a scale scored by the physician. The GOSE scores range from 1 (dead) to 8 (upper good recovery). The long-term clinical outcome assessed by the GOSE was dichotomized into poor outcome (score ≤ 4) and good outcome (score \> 4)
Outcome measures
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Long-term Clinical Outcome Assessed by the Glasgow Outcome Scale Extended (GOSE) at Week 12 Post-aSAH
Participants with a GOSE score less than and equal to 4
|
50 Participants
|
41 Participants
|
|
Long-term Clinical Outcome Assessed by the Glasgow Outcome Scale Extended (GOSE) at Week 12 Post-aSAH
Participant with a GOSE score greater than 4
|
152 Participants
|
163 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 14 days post-study drug initiationPopulation: Safety Analysis Set: all randomized participants who started study treatment, evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set.
Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms and computed tomography (CT) scans.
Outcome measures
| Measure |
Clazosentan
n=207 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=199 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation (Safety Analysis Set)
|
32 Participants
|
35 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 14 days post-study drug initiationPopulation: Full Analysis Set
Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms and Computed Tomograph (CT) scans.
Outcome measures
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation Including Rescue Therapy for Non-relevant Vasospasm
|
34 Participants
|
47 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 14 days post-study drug initiationPopulation: Full Analysis Set
Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms and Computed Tomograph (CT) scans.
Outcome measures
| Measure |
Clazosentan
n=202 Participants
All participants from the randomized analysis set who started clazosentan 15 mg per hour infusion for up to 14 days.
|
Placebo
n=204 Participants
All participants from the randomized analysis set who started matching placebo infusion for up to 14 days.
|
|---|---|---|
|
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation Based on Neurological Scales and Death
|
28 Participants
|
33 Participants
|
Adverse Events
Clazosentan
Serious events: 33 serious events
Other events: 156 other events
Deaths: 7 deaths
Placebo
Serious events: 26 serious events
Other events: 140 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Clazosentan
n=207 participants at risk
Participants that received at least one dose of clazosentan.
|
Placebo
n=199 participants at risk
Participants that received placebo.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
General disorders
Brain death
|
0.97%
2/207 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Meningitis
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Pneumonia
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Pseudomonas aeruginosa meningitis
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Septic shock
|
1.4%
3/207 • Number of events 3 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Aphasia
|
1.4%
3/207 • Number of events 3 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Brain oedema
|
1.9%
4/207 • Number of events 4 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Cerebral infarction
|
1.9%
4/207 • Number of events 4 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
1.0%
2/199 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.97%
2/207 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Cerebral microinfarction
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Cerebral vasoconstriction
|
6.3%
13/207 • Number of events 15 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
6.0%
12/199 • Number of events 13 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Delayed ischaemic neurological deficit
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Hydrocephalus
|
1.4%
3/207 • Number of events 3 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
1.5%
3/199 • Number of events 3 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Intracranial pressure increased
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Neurological decompensation
|
0.97%
2/207 • Number of events 4 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
1.0%
2/199 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Status epilepticus
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Product Issues
Device malfunction
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
2/207 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Surgical and medical procedures
Aneurysm repair
|
0.00%
0/207 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.50%
1/199 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Vascular disorders
Distributive shock
|
0.48%
1/207 • Number of events 1 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
0.00%
0/199 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
Other adverse events
| Measure |
Clazosentan
n=207 participants at risk
Participants that received at least one dose of clazosentan.
|
Placebo
n=199 participants at risk
Participants that received placebo.
|
|---|---|---|
|
General disorders
Pyrexia
|
20.3%
42/207 • Number of events 44 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
17.6%
35/199 • Number of events 38 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Pneumonia
|
6.3%
13/207 • Number of events 13 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
3.0%
6/199 • Number of events 7 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Infections and infestations
Urinary tract infection
|
12.1%
25/207 • Number of events 25 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
12.1%
24/199 • Number of events 24 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Investigations
Alanine aminotransferase increased
|
7.2%
15/207 • Number of events 16 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
7.0%
14/199 • Number of events 14 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Investigations
Aspartate aminotransferase increased
|
6.3%
13/207 • Number of events 13 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
4.5%
9/199 • Number of events 9 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.6%
24/207 • Number of events 24 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
10.1%
20/199 • Number of events 20 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
17/207 • Number of events 19 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
3.0%
6/199 • Number of events 6 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
12/207 • Number of events 14 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
4.0%
8/199 • Number of events 8 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Constipation
|
15.5%
32/207 • Number of events 37 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
14.1%
28/199 • Number of events 34 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Gastrointestinal disorders
Nausea
|
8.2%
17/207 • Number of events 17 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
3.0%
6/199 • Number of events 6 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.1%
25/207 • Number of events 28 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
15.6%
31/199 • Number of events 37 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.9%
33/207 • Number of events 34 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
14.6%
29/199 • Number of events 31 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
6/207 • Number of events 6 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
5.0%
10/199 • Number of events 10 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Cerebral vasoconstriction
|
10.6%
22/207 • Number of events 27 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
19.6%
39/199 • Number of events 56 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Headache
|
15.0%
31/207 • Number of events 42 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
11.6%
23/199 • Number of events 24 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Nervous system disorders
Intracranial pressure increased
|
6.3%
13/207 • Number of events 13 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
2.5%
5/199 • Number of events 5 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Psychiatric disorders
Insomnia
|
6.8%
14/207 • Number of events 14 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
5.5%
11/199 • Number of events 11 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Renal and urinary disorders
Polyuria
|
3.4%
7/207 • Number of events 8 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
5.0%
10/199 • Number of events 10 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.2%
15/207 • Number of events 15 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
1.5%
3/199 • Number of events 3 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.8%
12/207 • Number of events 12 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
1.0%
2/199 • Number of events 2 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Vascular disorders
Hypertension
|
4.8%
10/207 • Number of events 10 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
13.1%
26/199 • Number of events 28 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
|
Vascular disorders
Hypotension
|
8.7%
18/207 • Number of events 18 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
3.5%
7/199 • Number of events 9 • Adverse events were considered treatment-emergent, if the onset date was from the start of the first infusion on Day 1 to up to 24 hours after study treatment discontinuation. Study treatment was planned for up to 14 days.
Safety Analysis Set: evaluated according to the actual treatment received. Note that 5 participants randomized to placebo received at least 1 infusion of clazosentan and were analyzed as part of the clazosentan arm for this analysis set. All-cause mortality: 10 participants died (7 clazosentan, 3 placebo). For 2 of the participants in the clazosentan group, the reason for study discontinuation was reported as Adverse event, i.e., with fatal outcome (see Participant flow).
|
Additional Information
Idorsia Clinical Trial Information
Idorsia Pharmaceutical Ltd
Phone: +1 856 661 3721
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by the investigators must be submitted to the sponsor for review at least 30 days prior to submission for publication or presentation at a congress. Upon review, the sponsor may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.
- Publication restrictions are in place
Restriction type: OTHER