Trial Outcomes & Findings for Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. (NCT NCT03715153)
NCT ID: NCT03715153
Last Updated: 2023-06-05
Results Overview
The CARS2 total raw score range from 15 to 60. This scale is a behaviour rating scale intended to diagnose autism. A total score of 15 indicates that an individual behaviour is within normal limits, whereas a value of 60 indicates that the individual's behaviour is severly abnormal. In term of change from baseline, the greater the mean value decreases, the better it is.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
Change from baseline to Week 26
Results posted on
2023-06-05
Participant Flow
The following study periods are presented: 1. Double-blind period of 6 months (Week 0-Week 26): randomized groups are Bumetanide and Placebo. 2. Open-label active treatment period (Week 26-Week 52): all patients received Bumetanide.
Participant milestones
| Measure |
BUMETANIDE (S95008) Followed by Open-Label S95008
Participants will receive S95008 for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
|
PLACEBO Followed by Open-Label S95008
Participants will receive Placebo for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
|
|---|---|---|
|
Double-blind Period (From W0 to W26)
STARTED
|
107
|
104
|
|
Double-blind Period (From W0 to W26)
COMPLETED
|
90
|
95
|
|
Double-blind Period (From W0 to W26)
NOT COMPLETED
|
17
|
9
|
|
Open-label Period (From W26 to W52)
STARTED
|
86
|
92
|
|
Open-label Period (From W26 to W52)
COMPLETED
|
46
|
50
|
|
Open-label Period (From W26 to W52)
NOT COMPLETED
|
40
|
42
|
Reasons for withdrawal
| Measure |
BUMETANIDE (S95008) Followed by Open-Label S95008
Participants will receive S95008 for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
|
PLACEBO Followed by Open-Label S95008
Participants will receive Placebo for 6 months, 26 weeks, and then they will begin an open-label 6 month treatment period with S95008.
|
|---|---|---|
|
Double-blind Period (From W0 to W26)
Protocol Violation
|
1
|
1
|
|
Double-blind Period (From W0 to W26)
Non medical reason
|
8
|
2
|
|
Double-blind Period (From W0 to W26)
Adverse Event
|
8
|
6
|
|
Open-label Period (From W26 to W52)
Adverse Event
|
8
|
3
|
|
Open-label Period (From W26 to W52)
Non medical reason
|
31
|
38
|
|
Open-label Period (From W26 to W52)
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BUMETANIDE (S95008) Followed by Open-Label S95008
n=107 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL. Taken twice daily from weeks 0-26, followed by open-label S95008 for weeks 26-52.
|
PLACEBO Followed by Open-Label S95008
n=104 Participants
PLACEBO: Oral solution. Taken twice daily from weeks 0-26, followed by open-label S95008 for weeks 26-52.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
107 Participants
n=107 Participants
|
104 Participants
n=104 Participants
|
211 Participants
n=211 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=211 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=211 Participants
|
|
Age, Continuous
|
4.4 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
4.6 years
STANDARD_DEVIATION 1.1 • n=104 Participants
|
4.5 years
STANDARD_DEVIATION 1.2 • n=211 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=107 Participants
|
17 Participants
n=104 Participants
|
35 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=107 Participants
|
87 Participants
n=104 Participants
|
176 Participants
n=211 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hungary
|
8 participants
n=107 Participants
|
8 participants
n=104 Participants
|
16 participants
n=211 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=107 Participants
|
1 participants
n=104 Participants
|
3 participants
n=211 Participants
|
|
Region of Enrollment
Czechia
|
6 participants
n=107 Participants
|
6 participants
n=104 Participants
|
12 participants
n=211 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=107 Participants
|
11 participants
n=104 Participants
|
22 participants
n=211 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=107 Participants
|
3 participants
n=104 Participants
|
6 participants
n=211 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=107 Participants
|
17 participants
n=104 Participants
|
33 participants
n=211 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=107 Participants
|
15 participants
n=104 Participants
|
30 participants
n=211 Participants
|
|
Region of Enrollment
Poland
|
14 participants
n=107 Participants
|
13 participants
n=104 Participants
|
27 participants
n=211 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=107 Participants
|
15 participants
n=104 Participants
|
30 participants
n=211 Participants
|
|
Region of Enrollment
Slovakia
|
3 participants
n=107 Participants
|
2 participants
n=104 Participants
|
5 participants
n=211 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=107 Participants
|
2 participants
n=104 Participants
|
4 participants
n=211 Participants
|
|
Region of Enrollment
France
|
12 participants
n=107 Participants
|
11 participants
n=104 Participants
|
23 participants
n=211 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to Week 26The CARS2 total raw score range from 15 to 60. This scale is a behaviour rating scale intended to diagnose autism. A total score of 15 indicates that an individual behaviour is within normal limits, whereas a value of 60 indicates that the individual's behaviour is severly abnormal. In term of change from baseline, the greater the mean value decreases, the better it is.
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=107 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=104 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Childhood Autism Rating Scale, Second Edition (CARS2) Total Raw Score
|
-3.66 score on a scale
Standard Deviation 4.52
|
-3.88 score on a scale
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Change from baseline to Week 26The SRS-2 total raw score serves as an index of severity of social deficits in the autism spectrum. The total raw score ranges from 65 to 260. A value of 65 represents no symptoms disorders, a value of 260 represents a severe autism spectrum disorder. In terms of change from baseline, the greater the mean value decreases, the better it is.
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=105 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=104 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Social Responsiveness Scale, Second Edition (SRS-2) Total Raw Score
|
-16.3 score on a scale
Standard Deviation 21.9
|
-18.7 score on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: At Week 26Scale which assesses the severity of the illness and the global improvement of the patient under study treatment. It ranges from 1 (normal) through to 7 (amongst the most severely ill patients).
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=85 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=89 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Clinical Global Impression - Global Improvement (CGI-I) Score
|
2.9 score on a scale
Standard Deviation 0.8
|
3.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Change from baseline to Week 26Scale designated to measure adaptative behaviour The scale for behaviour ranges from 1 to 67. The more the score decreases, the better it is.
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=101 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=95 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Vineland Adaptative Behaviour Scale II (VABS II)
|
1.1 score on a scale
Standard Deviation 6.1
|
0.7 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Week 26Population: As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected.
Number of patients with clinically significant ECG abnormalities The 12-lead electrocardiogram (ECG) is a medical test that is recorded using leads, or nodes, attached to the body. Electrocardiograms (ECGs), capture the electrical activity of the heart and transfer it to graphed paper where abnormalities are reported and interpretated by the cardiologist.
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=78 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=77 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Number of Patients With Abnormalities in 12-leads Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected.
Number of patients with suicidal ideation or suicidal behavior. The scale is 0 to 5 with the highest suicidal behavior being a 5 and the absence of suicidal behavior or very minor behaviors are 0. However, statistical analysis was done by looking at the number of patients with suicidal behavior or suicidal ideation during their lifetime and during the last 6 months of treatment.
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=103 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=101 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
During lifetime: suicidal behavior
|
0 Participants
|
0 Participants
|
|
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
During lifetime: suicidal ideation
|
0 Participants
|
0 Participants
|
|
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
During the last 6 months in the study: suicidal behavior
|
NA Participants
Suicidal behavior was not evaluated during the past 6 months.
|
NA Participants
Suicidal behavior was not evaluated during the past 6 months.
|
|
Columbia-Suicide Severity Scale Children's Version (C-SSRS-C)
During the last 6 months in the study: suicidal ideation
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Missing values are cancelled
Acceptability and palatability criterion Based on your child's reactions (indirect rating), do you think that he/she found the administration method to be
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=99 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=102 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
5 (Very satisfactory)
|
53 Participants
|
58 Participants
|
|
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
4 (Satisfactory)
|
30 Participants
|
23 Participants
|
|
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
3 (Acceptable)
|
10 Participants
|
17 Participants
|
|
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
2 (Not very satisfactory)
|
5 Participants
|
3 Participants
|
|
Acceptability and Palatability Questionnaires - Only Descriptive Analyses
1 (Not satisfactory)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to week 26Population: As this measure was collected through week 26, only data gathered during the double-blind period for arms Bumetanide and Placebo were collected.
It represents the assessment of parent/legal representative perception of patient health related quality of life The values of the questionnaire range from 0 to 100. Higher scores indicate better HRQOL (Health-Related Quality of Life)
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=107 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=104 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Paediatric Quality of Life Inventory (PedsQL) Questionnaire
|
5.87 score on a scale
Standard Deviation 16.37
|
5.47 score on a scale
Standard Deviation 21.41
|
SECONDARY outcome
Timeframe: through week 52Population: The overall number of participants analyzed reflects the total number of individual patients analyzed. However, since the statistical analysis of TEAE occurrence was separated by period (double-blind, and open-label) many patients were counted once for each period, and thus the sum of participants in each row is greater than the total number of individual participants analyzed. Not all patients who participated in the double-blind period continued into the open-label period.
Outcome measures
| Measure |
BUMETANIDE (S95008)
n=107 Participants
BUMETANIDE/S95008: Oral solution dosed at 0.5 mg/mL Taken twice daily.
|
PLACEBO
n=104 Participants
PLACEBO: Oral solution Taken twice daily.
|
|---|---|---|
|
Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE)
Reported during the double-blind period (Week 0 - 26)
|
103 Participants
|
96 Participants
|
|
Number of Participants Experiencing at Least 1 Treatment Emergent Adverse Event (TEAE)
Reported during the open-label period (Week 26-52)
|
84 Participants
|
81 Participants
|
Adverse Events
S95008 - Double-blind Period (Week 0-26)
Serious events: 7 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo - Double-blind Period (Week 0-26)
Serious events: 3 serious events
Other events: 96 other events
Deaths: 0 deaths
S95008/S95008 - Open-Label Extension Period (Week 26-52)
Serious events: 7 serious events
Other events: 84 other events
Deaths: 0 deaths
Placebo/S95008 - Open-Label Extension Period (Week 26-52)
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
S95008 - Double-blind Period (Week 0-26)
n=107 participants at risk
Patients randomised in the bumetamide arm receiving bumetanide during the double-blind period (Week 0-Week 26)
|
Placebo - Double-blind Period (Week 0-26)
n=104 participants at risk
Patients randomised in the placebo arm receiving placebo during the double blind period (week 0 to week 26)
|
S95008/S95008 - Open-Label Extension Period (Week 26-52)
n=84 participants at risk
Patients initially randomized into the bumetamide arm for the double-blind period (Week 0-Week 26) and during the open-label period (Week 26-week 52)
|
Placebo/S95008 - Open-Label Extension Period (Week 26-52)
n=92 participants at risk
Patients initially randomized into the placebo arm for the double-blind period (Week 0-Week 26) and during the open-label period (Week 26-week 52)
|
|---|---|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Immune system disorders
Multisystem inflammatory syndrome
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Blood glucose increased
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.93%
1/107 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Nervous system disorders
Atonic seizures
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Nervous system disorders
Febrile convulsion
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.93%
1/107 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
2/107 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/84 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Gastroenteritis viral
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Rhinitis
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
Other adverse events
| Measure |
S95008 - Double-blind Period (Week 0-26)
n=107 participants at risk
Patients randomised in the bumetamide arm receiving bumetanide during the double-blind period (Week 0-Week 26)
|
Placebo - Double-blind Period (Week 0-26)
n=104 participants at risk
Patients randomised in the placebo arm receiving placebo during the double blind period (week 0 to week 26)
|
S95008/S95008 - Open-Label Extension Period (Week 26-52)
n=84 participants at risk
Patients initially randomized into the bumetamide arm for the double-blind period (Week 0-Week 26) and during the open-label period (Week 26-week 52)
|
Placebo/S95008 - Open-Label Extension Period (Week 26-52)
n=92 participants at risk
Patients initially randomized into the placebo arm for the double-blind period (Week 0-Week 26) and during the open-label period (Week 26-week 52)
|
|---|---|---|---|---|
|
Investigations
Blood creatinine increased
|
5.6%
6/107 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.9%
3/104 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
13.1%
11/84 • Number of events 11 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Blood uric acid increased
|
4.7%
5/107 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.0%
5/84 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.2%
2/92 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Weight decreased
|
12.1%
13/107 • Number of events 13 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
14.3%
12/84 • Number of events 13 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.9%
10/92 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
4/107 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.7%
7/104 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.1%
6/84 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.5%
6/92 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Nervous system disorders
Akathisia
|
7.5%
8/107 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.8%
4/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.3%
7/84 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.3%
4/92 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Nervous system disorders
Headache
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.8%
6/104 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.2%
2/92 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
General disorders
Fatigue
|
9.3%
10/107 • Number of events 11 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.3%
7/84 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.3%
4/92 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
General disorders
Pyrexia
|
9.3%
10/107 • Number of events 11 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.7%
8/104 • Number of events 13 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
15.5%
13/84 • Number of events 19 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
13.0%
12/92 • Number of events 13 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
General disorders
Thirst
|
57.9%
62/107 • Number of events 76 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
34.6%
36/104 • Number of events 40 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
59.5%
50/84 • Number of events 66 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
32.6%
30/92 • Number of events 36 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Affect lability
|
5.6%
6/107 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.7%
8/104 • Number of events 11 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.5%
6/92 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Aggression
|
6.5%
7/107 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.7%
9/104 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.0%
5/84 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.6%
7/92 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Anger
|
6.5%
7/107 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.7%
7/104 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.1%
6/84 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.3%
4/92 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Impulsive behavior
|
2.8%
3/107 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.7%
9/104 • Number of events 12 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.6%
3/84 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Anxiety
|
4.7%
5/107 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.9%
2/104 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.1%
6/84 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.5%
6/92 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Initial insomnia
|
5.6%
6/107 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.8%
6/104 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.1%
6/84 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Insomnia
|
8.4%
9/107 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.8%
6/104 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.3%
7/84 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.3%
3/92 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Irritability
|
15.0%
16/107 • Number of events 17 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
15.4%
16/104 • Number of events 19 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
19.0%
16/84 • Number of events 19 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
9.8%
9/92 • Number of events 11 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
8/107 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
9.5%
8/84 • Number of events 11 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.3%
3/92 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Constipation
|
9.3%
10/107 • Number of events 13 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
17.9%
15/84 • Number of events 18 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
9/107 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.6%
11/104 • Number of events 16 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
14.3%
12/84 • Number of events 15 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.9%
10/92 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Dry mouth
|
18.7%
20/107 • Number of events 27 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.6%
11/104 • Number of events 15 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
22.6%
19/84 • Number of events 29 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
9.8%
9/92 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
16/107 • Number of events 23 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
14.4%
15/104 • Number of events 19 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
19.0%
16/84 • Number of events 28 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.9%
10/92 • Number of events 12 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Renal and urinary disorders
Pollakiuria
|
9.3%
10/107 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.7%
9/84 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.2%
2/92 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Renal and urinary disorders
Polyuria
|
36.4%
39/107 • Number of events 46 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
22.1%
23/104 • Number of events 25 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
39.3%
33/84 • Number of events 43 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
28.3%
26/92 • Number of events 27 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
5/107 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.9%
17/107 • Number of events 17 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
15.4%
16/104 • Number of events 18 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
17.9%
15/84 • Number of events 19 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.9%
10/92 • Number of events 12 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.0%
16/107 • Number of events 29 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.9%
2/104 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
21.4%
18/84 • Number of events 37 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
22.8%
21/92 • Number of events 35 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.93%
1/107 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.8%
6/104 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.4%
2/84 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.3%
4/92 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Increased appetite
|
13.1%
14/107 • Number of events 14 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
9.6%
10/104 • Number of events 15 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
17.9%
15/84 • Number of events 16 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.3%
3/92 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Metabolism and nutrition disorders
Polydipsia
|
7.5%
8/107 • Number of events 8 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.8%
4/104 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.3%
7/84 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.2%
2/92 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Gastroenteritis viral
|
8.4%
9/107 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.7%
9/84 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Gastroenteritis
|
2.8%
3/107 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/92 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Nasopharyngitis
|
11.2%
12/107 • Number of events 17 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.6%
11/104 • Number of events 14 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
19.0%
16/84 • Number of events 27 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
10.9%
10/92 • Number of events 13 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
6/107 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.8%
4/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.3%
7/84 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.1%
1/92 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.6%
6/107 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.7%
7/104 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
8.3%
7/84 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Glomerular filtration rate decreased
|
1.9%
2/107 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.8%
4/104 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
11.9%
10/84 • Number of events 10 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Creatinine urine dedreased
|
3.7%
4/107 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.1%
6/84 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.2%
2/92 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Investigations
Urine calcium increased
|
3.7%
4/107 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
7.1%
6/84 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.5%
6/92 • Number of events 6 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Renal and urinary disorders
Hypercalciuria
|
3.7%
4/107 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.96%
1/104 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.2%
2/92 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/107 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
0.00%
0/104 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 9 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Psychiatric disorders
Enuresis
|
3.7%
4/107 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
1.9%
2/104 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
4/84 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.3%
4/92 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.9%
2/107 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.3%
3/92 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Pharyngitis
|
0.93%
1/107 • Number of events 1 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
4.8%
5/104 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.3%
3/92 • Number of events 4 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
|
Infections and infestations
Rhinitis
|
1.9%
2/107 • Number of events 2 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
6.7%
7/104 • Number of events 7 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
3.6%
3/84 • Number of events 3 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
5.4%
5/92 • Number of events 5 • Adverse events were collected throughout the study until the participant's last study visit, ie 1 year.
During the double blind period, the Treatment Emergent Adverse Events (TEAEs) were analyzed between week 0 and week 26. During the open-label period for patients initially randomized in placebo group (Placebo/S95008), TEAEs were analyzed between Week 26 and Week 52 (ie when these patients received bumetanide). For patients initially randomized in S950098 group and entering in the open-label period (S95008/S95008), treatment emergent adverse events were analyzed from week 0 to week 52.
|
Additional Information
Dr. Pierre-François PENELAUD
Institut de Recherches Internationales Servier (I.R.I.S.)
Phone: + 33 1 55 72 68 58
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place